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

Aalborg University46 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: ALLMin age: 10 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Locations (4)

Århus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Aalborg University

Gistrup, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Isometric strength

Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry

Time frame: Baseline and at the 8-week and 16-week follow-ups

Secondary Outcomes

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

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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'.

Time frame: During the 16-week follow-up

Blood glucose

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

Glycated hemoglobin (Hba1c)

Analysed from a blood sample and measured in mmol/mol

Time frame: During baseline and at the 16-week follow-up

Insulin

Analysed from a blood sample and measured in mU/L

Time frame: During baseline and at the 16-week follow-up

Proinsulin c-peptide

Analysed from a blood sample and measured in ng/mL

Time frame: During baseline and at the 16-week follow-up

Total cholesterol

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

High-density lipoprotein cholesterol

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

Low-density lipoprotein cholesterol

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

Very low-density lipoprotein cholesterol

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

Triglycerides

Analysed from a blood sample and measured in mmol/L

Time frame: During baseline and at the 16-week follow-up

Glucagon

Analysed from a blood sample and measured in pg/mL

Time frame: 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)

Time frame: 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.

Time frame: During baseline and at the 16-week follow-up

Lean body mass

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)

Time frame: During baseline and at the 16-week follow-up

Fat mass

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)

Time frame: 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

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes