Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

Cancer Clinical Trial

— STEEL  

Official title:

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - The STEEL Study - a National Multicenter Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299722
• Other study ID #: N-20230055
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Aalborg University
• Contact: Henrik Riel, PhD
• Phone: +4530201570
• Email: hriel[@]dcm.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

Description:

The trial is designed as a national randomised clinical trial. Participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or the circuit training programme. A researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. The study will be conducted at Aalborg University Hospital, Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. Participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Ten to 19 years of age at the point of inclusion
• A minimum of 12 months since the last chemotherapy with no upper limit
• Ability to understand the physical intervention and general participant advice

Exclusion Criteria:

• Participation in another research study that includes similar treatment
• Pregnancy
• Cardiac arrhythmia during exercise
• Psychological disorders interfering with treatment
• Presence of a clinical condition that needs immediate treatment
• Planned surgeries within the subsequent 12 months that may interfere with performing exercises
• Any contraindications to performing physical exercise as evaluated by the recruiting medical doctor

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Lymphoma

Intervention

Other:
• STEEL
Relatively heavy strength training
• Circuit training
Circuit training

Locations

Country	Name	City	State
Denmark	Århus University Hospital	Århus
Denmark	Rigshospitalet	Copenhagen
Denmark	Aalborg University	Gistrup
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric strength	Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry	Baseline and at the 8-week and 16-week follow-ups
Secondary	Health-related quality of life	We will use the Danish version of the Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core scales and the PedsQL™ Multidimensional Fatigue scales (5,9) to assess health-related quality of life. The PedsQL is a brief 23-item measurement model that evaluates quality of life in four areas: physical, emotional, social and school functioning. The questionnaire scores range from 0 to 100, and higher scores indicate better quality of life. The PedsQL™ Multidimensional Fatigue includes 18 questions related to fatigue and uses the same scoring as the PedsQL	During baseline and at the 16-week follow-up
Secondary	Step counts	We will assess participants' step counts throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).	Weekly throughout the 16-week intervention
Secondary	Caloric expenditure	We will assess participants' caloric expenditure (KCAL) throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).	Weekly throughout the 16-week intervention
Secondary	Maximal dynamic strength	we will test the 1 repetition maximum (RM) in the leg press and chest press machines	During the first and last training sessions of the 16-week intervention
Secondary	Bone mineral density of the lumbar spine and body composition	We will measure the bone mineral density of the lumbar spine (L1-L4) calculated as the Z-score and body composition (%body fat, lean body mass, and skeletal muscle mass) by a dual-energy-X-ray absorptiometry scanner located at each hospital.	During baseline and at the 16-week follow-up
Secondary	Grip strength and rate of force development	Using a digital hand dynamometer, we will measure continuous isometric handgrip force and rate of force development.	Baseline and at the 8-week and 16-week follow-ups
Secondary	Muscular strength, endurance, and rate of force development	We will use a 30-second sit-to-stand test to evaluate strength, endurance, and rate of force development of the lower extremities.	Baseline and at the 8-week and 16-week follow-ups
Secondary	Cardiorespiratory fitness and endurance	We will perform a 6-minute walk test to evaluate cardiorespiratory fitness and walking endurance	Baseline and at the 8-week and 16-week follow-ups
Secondary	Exercise compliance and fidelity	Exercise compliance and fidelity will be measured using training diaries, which the participants fill out themselves after the unsupervised training sessions and by the physiotherapist during the supervised training sessions. Exercise compliance relates to whether the training sessions have been performed, and fidelity relates to whether the exercises have been performed as prescribed regarding the number of repetitions, sets, and intensity.	Throughout the 16-week intervention
Secondary	Adverse events	Adverse events will be collected throughout the trial and graded 1 to 5 according to the Common Terminology Criteria for Adverse Events v4.03. Participants are asked to contact the responsible clinician at the hospital where they were enrolled as soon as they experience any adverse event.	Throughout the 16-week intervention
Secondary	Movement-evoked pain	We will use a 0 (no pain) to 10 (worst pain imaginable) Numerical Rating Scale to assess movement-evoked pain during the past week	During baseline and at the 16-week follow-up
Secondary	Satisfaction with the intervention	We will assess participant satisfaction with their respective intervention using a 5-point rank scale ranging from 'very dissatisfied' to 'very satisfied'.	During the 16-week follow-up
Secondary	Blood glucose	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	Glycated hemoglobin (Hba1c)	Analysed from a blood sample and measured in mmol/mol	During baseline and at the 16-week follow-up
Secondary	Insulin	Analysed from a blood sample and measured in mU/L	During baseline and at the 16-week follow-up
Secondary	Proinsulin c-peptide	Analysed from a blood sample and measured in ng/mL	During baseline and at the 16-week follow-up
Secondary	Total cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	High-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	Low-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	Very low-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	Triglycerides	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Secondary	Glucagon	Analysed from a blood sample and measured in pg/mL	During baseline and at the 16-week follow-up
Secondary	Homeostatic Model assessment for Insulin resistance score	Calculated as fasting plasma glucose (mmol/L x fasting plasma glucose ((µU/L)/22.5) to estimate ß-cell function (HOMA-B) and insulin-resistance (HOMA-IR2)	During baseline and at the 16-week follow-up
Secondary	Body Mass Index (BMI)	Measured as kg/m² for adolescents aged 18 or 19 years and BMI standard deviation (SD) scores for children aged 10-17 years based on national reference material.	During baseline and at the 16-week follow-up
Secondary	Lean body mass	Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)	During baseline and at the 16-week follow-up
Secondary	Fat mass	Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)	During baseline and at the 16-week follow-up
Secondary	Android/gynoid fat distribution	Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) adjusted for sex and pubertal stage	During baseline and at the 16-week follow-up
Secondary	Abdominal circumference	Measured in centimetres	During baseline and at the 16-week follow-up
Secondary	Self-reported Tanner staging	Visual illustration of Tanner staging (I-V) regarding both genders	During baseline and at the 16-week follow-up
Secondary	Blood pressure	Measured in mmHg	During baseline and at the 16-week follow-up