Lymphoma Clinical Trial
— INTERACTOfficial title:
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness. The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior. To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).
| Status | Recruiting |
| Enrollment | 127 |
| Est. completion date | September 2026 |
| Est. primary completion date | September 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 18 Years |
| Eligibility | Inclusion Criteria: - All malign and benign disorders treated with chemotherapy and/or irradiation Exclusion Criteria: - Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated - terminal illness - unable to communicate in Danish |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital | Aarhus | |
| Denmark | Rigshospitalet | Copenhagen | |
| Denmark | Odense University Hospital | Odense |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | Aarhus University Hospital, Odense University Hospital |
Denmark,
Fiuza-Luces C, Padilla JR, Soares-Miranda L, Santana-Sosa E, Quiroga JV, Santos-Lozano A, Pareja-Galeano H, Sanchis-Gomar F, Lorenzo-Gonzalez R, Verde Z, Lopez-Mojares LM, Lassaletta A, Fleck SJ, Perez M, Perez-Martinez A, Lucia A. Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Med Sci Sports Exerc. 2017 Feb;49(2):223-230. doi: 10.1249/MSS.0000000000001094. — View Citation
Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544. — View Citation
Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Metabolomics (explorative outcome) | Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer. | within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment. | |
| Other | Metabolomics (explorative outcome) | Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer. | 6 months after inclusion (before a treatment block. | |
| Other | Metabolomics (explorative outcome) | Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer. | 1 month after ended treatment. | |
| Other | Metabolomics (explorative outcome) | Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer. | 1 year after end of treatment. | |
| Other | Dietary assessment (explorative outcome) | Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com) | within 2 weeks of treatment initiation | |
| Other | Dietary assessment (explorative outcome) | Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com) | 6 months after inclusion (before a treatment block), | |
| Other | Dietary assessment (explorative outcome) | Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com) | 1 month after ended treatment. | |
| Other | Dietary assessment (explorative outcome) | Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com) | 1 year after end of treatment. | |
| Other | Intestinal microbiota (explorative outcome) | Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark | within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment. | |
| Other | Intestinal microbiota (explorative outcome) | Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark | within 2 weeks of treatment initiation. | |
| Other | Intestinal microbiota (explorative outcome) | Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark | 6 months after inclusion (before a treatment block. | |
| Other | Intestinal microbiota (explorative outcome) | Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark | 1month after ended treatment. | |
| Other | Intestinal microbiota (explorative outcome) | Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark | 1 year after end of treatment. | |
| Other | Inflammatory cytokines and mediators (explorative outcome) | Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-a) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet. | within 2 weeks of treatment initiation | |
| Other | Inflammatory cytokines and mediators (explorative outcome) | Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-a) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet. | 6 months after inclusion (before a treatment block). | |
| Other | Inflammatory cytokines and mediators (explorative outcome) | Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-a) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet. | 1 month after ended treatment. | |
| Other | Inflammatory cytokines and mediators (explorative outcome) | Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-a) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet. | 1 year after end of treatment. | |
| Other | Growth and Reproduction (explorative outcome) | DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-a)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet. | within 2 weeks of treatment initiation. | |
| Other | Growth and Reproduction (explorative outcome) | DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-a)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet. | 6 months after inclusion (before a treatment block) | |
| Other | Growth and Reproduction (explorative outcome) | DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-a)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet. | 1 month after ended treatment. | |
| Other | Growth and Reproduction (explorative outcome) | DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-a)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet. | 1 year after end of treatment. | |
| Other | Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome) | All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform. Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted. Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump. |
Within 2 weeks of treatment initiation (baseline) | |
| Other | Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome) | All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform. Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted. Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump. |
6-months after inclusion | |
| Other | Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome) | All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform. Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted. Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump. |
3-months after inclusion | |
| Other | Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome) | All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform. Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted. Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump. |
1 month after ended treatment | |
| Other | Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome) | All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform. Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted. Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump. |
1 year after ended treatment | |
| Other | Neuropathy - Ped-mTNS (explorative outcome) | Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes. | Within 2 weeks of treatment initiation (baseline) | |
| Other | Neuropathy - Ped-mTNS (explorative outcome) | Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes. | 3-months after inclusion | |
| Other | Neuropathy - Ped-mTNS (explorative outcome) | Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes. | 6-months after inclusion | |
| Other | Neuropathy - Ped-mTNS (explorative outcome) | Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes. | one month after ended treatment | |
| Other | Neuropathy - Ped-mTNS (explorative outcome) | Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes. | 1 year after ended treatment | |
| Other | Physio- and occupational therapy treatments (explorative outcome) | Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records. | measured 6 months after inclusion | |
| Other | Physio- and occupational therapy treatments (explorative outcome) | Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records. | 1 month after ended treatment | |
| Other | Physio- and occupational therapy treatments (explorative outcome) | Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records. | 1 year after ended treatment | |
| Other | General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome) | An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups. | Within 2 weeks of treatment initiation. | |
| Other | General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report: (explorative outcome) | An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups. | 6-months after inclusion. | |
| Other | General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome) | An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups. | 1 month after ended treatment. | |
| Other | General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome) | An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups. | 1 year after ended treatment. | |
| Other | The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report | The PedsQL 3.0 Cancer Module instrument encompasses eight subscales: (1) pain and hurt, (2) nausea, (3) procedural anxiety, (4) treatment anxiety, (5) worry, (6) cognitive problems, (7) perceived physical appearance, and (8) communication | Within 2 weeks of treatment initiation. | |
| Other | The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome) | The PedsQL 3.0 Cancer Module instrument encompasses eight subscales: (1) pain and hurt, (2) nausea, (3) procedural anxiety, (4) treatment anxiety, (5) worry, (6) cognitive problems, (7) perceived physical appearance, and (8) communication | 6 months after inclusion | |
| Other | PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome) | Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue. | Within 2 weeks of treatment initiation. | |
| Other | PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome) | Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue. | 6 months after inclusion. | |
| Other | PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome) | Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue. | 1 month after ended treatment. | |
| Other | PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome) | Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue. | 1 year after end of treatment. | |
| Other | Self-Efficacy for Exercise scale (SEE-DK) (explorative outcome) | Self-efficacy for exercise is measured using the Danish version of the SEE scale. This scale contains nine-items concerning nine different potential barriers (weather, activity being tedious, pain, loneliness, disliking the activity, irrelevance, fatigue, stress, sadness) to perform physical exercise. | monthly, up to 6 months after inclusion | |
| Other | Modified Clinical Test of Sensory Interaction in Balance (explorative outcome) | This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds. |
Within 2 weeks of treatment initiation (baseline) | |
| Other | Modified Clinical Test of Sensory Interaction in Balance (explorative outcome) | This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds. |
3-months after inclusion | |
| Other | Modified Clinical Test of Sensory Interaction in Balance (explorative outcome) | This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds. |
6-months after inclusion | |
| Other | Modified Clinical Test of Sensory Interaction in Balance (explorative outcome) | This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds. |
1 month after ended treatment | |
| Other | Modified Clinical Test of Sensory Interaction in Balance (explorative outcome) | This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds. |
1 year after ended treatment | |
| Other | Facilitators and Barriers to Physical Activity, semi-structured in-depth interviews (explorative outcome) | We will interview at least 20 children and their parents from the intervention and control group purposely sampled to represent children with high and low physical activity levels, from all centers, representatives for age, diagnosis and sex. | within 6-months after treatment initiation | |
| Other | Physical Activity behaviour (explorative outcome) | Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time. | 1 year after ended treatment. | |
| Other | Physical Activity behaviour (explorative outcome) | Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time. | 1 month after ended treatment. | |
| Other | Physical Activity behaviour (explorative outcome) | Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time. | 6-months after inclusion (primary endpoint). | |
| Other | Physical Activity behaviour (explorative outcome) | Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time. | 3-months after inclusion | |
| Other | Physical Activity behaviour (explorative outcome) | Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time. | Within 2 weeks of treatment initiation | |
| Other | Risk factors of metabolic syndrome: Body Mass Index | Weight and Height is combined to report BMI in kg/m^2 | within 2 weeks of treatment initiation | |
| Other | Risk factors of metabolic syndrome: Body Mass Index | Weight and Height is combined to report BMI in kg/m^2 | 6 months after inclusion (before a treatment block) | |
| Other | Risk factors of metabolic syndrome: Body Mass Index | Weight and Height is combined to report BMI in kg/m^2 | 1 month after ended treatment | |
| Other | Risk factors of metabolic syndrome: Body Mass Index | Weight and Height is combined to report BMI in kg/m^2 | 1 year after end of treatment (primary endpoint) | |
| Other | Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol | Blood samples is reported in mmol/L | within 2 weeks of treatment initiation | |
| Other | Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol | Blood samples is reported in mmol/L | 6 months after inclusion (before a treatment block) | |
| Other | Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol | Blood samples is reported in mmol/L | 1 month after ended treatment | |
| Other | Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol | Blood samples is reported in mmol/L | 1 year after end of treatment (primary endpoint) | |
| Other | Risk factors of metabolic syndrome: Oral Glucose Tolerance Test | An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California). | within 2 weeks of treatment initiation | |
| Other | Risk factors of metabolic syndrome: Oral Glucose Tolerance Test | An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California). | 6 months after inclusion (before a treatment block) | |
| Other | Risk factors of metabolic syndrome: Oral Glucose Tolerance Test | An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California). | 1 month after ended treatment | |
| Other | Risk factors of metabolic syndrome: Oral Glucose Tolerance Test | An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California). | 1 year after end of treatment (primary endpoint) | |
| Other | Risk factors of metabolic syndrome: hip circumference | Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Other | Risk factors of metabolic syndrome: hip circumference | Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Other | Risk factors of metabolic syndrome: hip circumference | Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Other | Risk factors of metabolic syndrome: hip circumference | Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 year after end of treatment (primary endpoint) | |
| Primary | Lower extremity isometric knee extension strength | Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing. |
Within 2 weeks of treatment initiation (baseline) | |
| Primary | Lower extremity isometric knee extension strength | Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing. |
3-months after inclusion | |
| Primary | Lower extremity isometric knee extension strength | Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing. |
6-months after inclusion (primary endpoint) | |
| Primary | Lower extremity isometric knee extension strength | Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing. |
1 month after ended treatment | |
| Primary | Lower extremity isometric knee extension strength | Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted. The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground. The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing. |
1 year after ended treatment | |
| Secondary | Markers of metabolic syndrome: Waist circumference (primary secondary outcome) | Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Secondary | Markers of metabolic syndrome: triglycerides (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Secondary | Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Secondary | Markers of metabolic syndrome: blood pressure (primary secondary outcome) | Blood pressure (mmHg) will be measured in the morning and in the right arm with the subject in the sitting position. TMarkers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Secondary | Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | within 2 weeks of treatment initiation | |
| Secondary | Markers of metabolic syndrome: Waist circumference (primary secondary outcome) | Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Secondary | Markers of metabolic syndrome: triglycerides (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Secondary | Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Secondary | Markers of metabolic syndrome: blood pressure (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Secondary | Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 6 months after inclusion (before a treatment block) | |
| Secondary | Markers of metabolic syndrome: Waist circumference (primary secondary outcome) | Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Secondary | Markers of metabolic syndrome: triglycerides (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Secondary | Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Secondary | Markers of metabolic syndrome: blood pressure (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Secondary | Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 month after ended treatment | |
| Secondary | Markers of metabolic syndrome: Waist circumference (primary secondary outcome) | Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3. | 1 year after end of treatment (primary endpoint) | |
| Secondary | Markers of metabolic syndrome: triglycerides (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 year after end of treatment (primary endpoint) | |
| Secondary | Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 year after end of treatment (primary endpoint) | |
| Secondary | Markers of metabolic syndrome: blood pressure (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 year after end of treatment (primary endpoint) | |
| Secondary | Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome) | Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3). | 1 year after end of treatment (primary endpoint) | |
| Secondary | Isometric Bench Press | Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force. |
Within 2 weeks of treatment initiation (baseline) | |
| Secondary | Isometric Bench Press | Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force. |
3-months after inclusion | |
| Secondary | Isometric Bench Press | Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force. |
6-months after inclusion (primary endpoint) | |
| Secondary | Isometric Bench Press | Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force. |
1 month after ended treatment | |
| Secondary | Isometric Bench Press | Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force. |
1 year after ended treatment | |
| Secondary | Hand Grip strength | Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function. | Within 2 weeks of treatment initiation (baseline) | |
| Secondary | Hand Grip strength | Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function. | 3-months after inclusion | |
| Secondary | Hand Grip strength | Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function. | 6-months after inclusion (primary endpoint) | |
| Secondary | Hand Grip strength | Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function. | 1 month after ended treatment | |
| Secondary | Hand Grip strength | Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function. | 1 year after ended treatment | |
| Secondary | Six Minutes Walk Test | Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale. | Within 2 weeks of treatment initiation (baseline) | |
| Secondary | Six Minutes Walk Test | Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale. | 3-months after inclusion | |
| Secondary | Six Minutes Walk Test | Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale. | 6-months after inclusion (primary endpoint) | |
| Secondary | Six Minutes Walk Test | Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale. | 1 month after ended treatment | |
| Secondary | Six Minutes Walk Test | Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale. | 1 year after ended treatment | |
| Secondary | Thirty Seconds and One-Minute Sit-to-stand | Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted. | Within 2 weeks of treatment initiation (baseline) | |
| Secondary | Thirty Seconds and One-Minute Sit-to-stand | Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted. | 3-months after inclusion | |
| Secondary | Thirty Seconds and One-Minute Sit-to-stand | Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted. | 6-months after inclusion (primary endpoint) | |
| Secondary | The timed Up-and-Go Test: | The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis. |
3-months after inclusion | |
| Secondary | Thirty Seconds and One-Minute Sit-to-stand | Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted. | 1 month after ended treatment | |
| Secondary | Thirty Seconds and One-Minute Sit-to-stand | Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted. | 1 year after ended treatment | |
| Secondary | The timed Up-and-Go Test: | The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis. |
Within 2 weeks of treatment initiation (baseline) | |
| Secondary | The timed Up-and-Go Test: | The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis. |
6-months after inclusion (primary endpoint) | |
| Secondary | The timed Up-and-Go Test: | The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis. |
1 month after ended treatment | |
| Secondary | The timed Up-and-Go Test: | The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis. |
1 year after ended treatment | |
| Secondary | Hospitalized days | Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records | measured 6 months after inclusion (primary endpoint) | |
| Secondary | Hospitalized days | Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records | 1month after ended treatment | |
| Secondary | Hospitalized days | Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records | 1 year after ended treatment | |
| Secondary | Body composition: Bone Mineral Density | Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | within 2 weeks of treatment initiation | |
| Secondary | Body composition: Bone Mineral Content | Bone Mineral content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | within 2 weeks of treatment initiation | |
| Secondary | Body composition: Body Fat | Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | within 2 weeks of treatment initiation | |
| Secondary | Body composition: Fat-Free Mass | Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | within 2 weeks of treatment initiation | |
| Secondary | Body composition: Bone Mineral Density | Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 6 months after inclusion (before a treatment block) | |
| Secondary | Body composition: Bone Mineral Content | Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 6 months after inclusion (before a treatment block) | |
| Secondary | Body composition: Body Fat | Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 6 months after inclusion (before a treatment block) | |
| Secondary | Body composition: Fat-Free Mass | Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 6 months after inclusion (before a treatment block) | |
| Secondary | Body composition: Bone Mineral Density | Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 month after ended treatment. | |
| Secondary | Body composition: Bone Mineral Content | Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 month after ended treatment. | |
| Secondary | Body composition: Body Fat | Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 month after ended treatment. | |
| Secondary | Body composition: Fat-Free Mass | Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 month after ended treatment. | |
| Secondary | Body composition: Bone Mineral Density | Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 year after end of treatment (primary endpoint). | |
| Secondary | Body composition: Bone Mineral Content | Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 year after end of treatment (primary endpoint). | |
| Secondary | Body composition: Body Fat | Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 year after end of treatment (primary endpoint). | |
| Secondary | Body composition: Fat-Free Mass | Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body. | 1 year after end of treatment (primary endpoint). | |
| Secondary | The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report: | The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity. | Within 2 weeks of treatment initiation | |
| Secondary | The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report: | The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity. | 6-months after inclusion. | |
| Secondary | The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report: | The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity. | 1 month after ended treatment | |
| Secondary | The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report: | The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity. | 1 year after ended treatment | |
| Secondary | Prevalence of metabolic syndrome | Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study. | within 2 weeks of treatment initiation. | |
| Secondary | Prevalence of metabolic syndrome | Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study. | 6 months after inclusion (before a treatment block) | |
| Secondary | Prevalence of metabolic syndrome | Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study. | 1 month after ended treatment. | |
| Secondary | Prevalence of metabolic syndrome | Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study. | 1 year after end of treatment (primary endpoint) |
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