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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: STEEL; Other: Circuit training

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Riel, PhD; Phone Number: +4530201570; Email: hriel@dcm.aau.dk
• Study Contact Backup: Name: Pascal Madeleine, DSc; Email: pm@hst.aau.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Martin K Fridh; Email: martin.kaj.fridh@regionh.dk
  • Gistrup, Denmark, 9260
    • Recruiting
    • Aalborg University
    • Contact: Henrik Riel; Email: hriel@dcm.aau.dk
  • Odense, Denmark
    • Recruiting
    • Odense University Hospital
    • Contact: Mathias Rathe; Email: mathias.rathe@rsyd.dk
  • Århus, Denmark
    • Recruiting
    • Århus University Hospital
    • Contact: Clara Vad; Email: claravad@live.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEEL; STEEL strength training will consist of progressive periodised training, in which the intensity is set to fit the individual's starting level and then gradually increases. During Week 1 to Week 5, the relative load will correspond to a 12-repetition maximum (RM). During Week 5 to Week 10, the relative load will be 10 RM, and during Week 11 to Week 16, the relative load will be 8 RM. The exercises will mostly consist of compound movements that activate the large muscle groups of the legs, back, arms and torso.	Other: STEEL; Relatively heavy strength training
Active Comparator: Circuit training; There will be 10 stations that include both strengthening and cardiovascular exercises, such as squats, hopping, crunches, stationary running, front-lying swimming, ski jumps, push-ups, ball throws, ring pulls, and hopscotch. Each station lasts 45 seconds, and there will be a 15-second break between each station. The circuit is repeated for three rounds. To ensure progression in intensity similar, we will progress the participants' rating of perceived exertion (RPE) over time. During Week 1 to Week 5, the RPE during exercises will be 6-7. During Week 5 to Week 10, the RPE will be 8-9, and during Week 11 to Week 16, the RPE will be 10.	Other: Circuit training; Circuit training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Blood glucose	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Glycated hemoglobin (Hba1c)	Analysed from a blood sample and measured in mmol/mol	During baseline and at the 16-week follow-up
Insulin	Analysed from a blood sample and measured in mU/L	During baseline and at the 16-week follow-up
Proinsulin c-peptide	Analysed from a blood sample and measured in ng/mL	During baseline and at the 16-week follow-up
Total cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
High-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Low-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Very low-density lipoprotein cholesterol	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Triglycerides	Analysed from a blood sample and measured in mmol/L	During baseline and at the 16-week follow-up
Glucagon	Analysed from a blood sample and measured in pg/mL	During baseline and at the 16-week follow-up
Homeostatic Model assessment for Insulin resistance score	Calculated as fasting plasma glucose (mmol/L x fasting plasma glucose ((μU/L)/22.5) to estimate β-cell function (HOMA-B) and insulin-resistance (HOMA-IR2)	During baseline and at the 16-week follow-up
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
Lean body mass	Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)	During baseline and at the 16-week follow-up
Fat mass	Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)	During baseline and at the 16-week follow-up
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
Abdominal circumference	Measured in centimetres	During baseline and at the 16-week follow-up
Self-reported Tanner staging	Visual illustration of Tanner staging (I-V) regarding both genders	During baseline and at the 16-week follow-up
Blood pressure	Measured in mmHg	During baseline and at the 16-week follow-up

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Study Chair: Pascal Madeleine, DSc, Aalborg University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Lymphoma; Leukemia
• Other Study ID Numbers: N-20230055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No