Childhood Cancer Clinical Trial
Official title:
Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence
Verified date | May 2021 |
Source | Technische Universität München |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).
Status | Completed |
Enrollment | 40 |
Est. completion date | February 25, 2021 |
Est. primary completion date | February 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: - Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma - Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München - Informed consent as documented by signature Exclusion Criteria: - Medical contraindications regarding strength training (e.g. risk of bleeding, ...) - Contraindications to one of the inclusion criteria mentioned above - Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc. |
Country | Name | City | State |
---|---|---|---|
Germany | Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of score of the Activities Scale for Kids - performance version | The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer). | Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months | |
Secondary | Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON) | Motor performance is assessed by the MOON-test, a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children. | Change of motor performance from baseline to 6 months | |
Secondary | Change of level of physical activity | Physical activity is assessed using an accelerometer (movisens) for the period of 7 days. | Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months | |
Secondary | Change in performance in a parkour in activities of daily living | A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed. | Change of score in the parkour from baseline to 6 months |
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