Cancer
Conditions
Brief 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).
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.
Interventions
OTHERSTEEL
Relatively heavy strength training
OTHERCircuit training
Circuit training
Sponsors
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isometric strength | Baseline and at the 8-week and 16-week follow-ups | Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Very low-density lipoprotein cholesterol | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| Triglycerides | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| Glucagon | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in pg/mL |
| Health-related quality of life | During baseline and at the 16-week follow-up | 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 |
| Step counts | Weekly throughout the 16-week intervention | We will assess participants' step counts throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA). |
| Caloric expenditure | Weekly throughout the 16-week intervention | We will assess participants' caloric expenditure (KCAL) throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA). |
| Maximal dynamic strength | During the first and last training sessions of the 16-week intervention | we will test the 1 repetition maximum (RM) in the leg press and chest press machines |
| Bone mineral density of the lumbar spine and body composition | During baseline and at the 16-week follow-up | 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. |
| Grip strength and rate of force development | Baseline and at the 8-week and 16-week follow-ups | Using a digital hand dynamometer, we will measure continuous isometric handgrip force and rate of force development. |
| Muscular strength, endurance, and rate of force development | Baseline and at the 8-week and 16-week follow-ups | We will use a 30-second sit-to-stand test to evaluate strength, endurance, and rate of force development of the lower extremities. |
| Cardiorespiratory fitness and endurance | Baseline and at the 8-week and 16-week follow-ups | We will perform a 6-minute walk test to evaluate cardiorespiratory fitness and walking endurance |
| Exercise compliance and fidelity | Throughout the 16-week intervention | 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. |
| Adverse events | Throughout the 16-week intervention | 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. |
| Movement-evoked pain | During baseline and at the 16-week follow-up | We will use a 0 (no pain) to 10 (worst pain imaginable) Numerical Rating Scale to assess movement-evoked pain during the past week |
| Low-density lipoprotein cholesterol | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| Blood glucose | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| Glycated hemoglobin (Hba1c) | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/mol |
| Insulin | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mU/L |
| Proinsulin c-peptide | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in ng/mL |
| Total cholesterol | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| High-density lipoprotein cholesterol | During baseline and at the 16-week follow-up | Analysed from a blood sample and measured in mmol/L |
| Homeostatic Model assessment for Insulin resistance score | During baseline and at the 16-week follow-up | 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) |
| Body Mass Index (BMI) | During baseline and at the 16-week follow-up | 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. |
| Lean body mass | During baseline and at the 16-week follow-up | Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) |
| Fat mass | During baseline and at the 16-week follow-up | Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) |
| Android/gynoid fat distribution | During baseline and at the 16-week follow-up | Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) adjusted for sex and pubertal stage |
| Abdominal circumference | During baseline and at the 16-week follow-up | Measured in centimetres |
| Self-reported Tanner staging | During baseline and at the 16-week follow-up | Visual illustration of Tanner staging (I-V) regarding both genders |
| Blood pressure | During baseline and at the 16-week follow-up | Measured in mmHg |
| Satisfaction with the intervention | During the 16-week follow-up | We will assess participant satisfaction with their respective intervention using a 5-point rank scale ranging from 'very dissatisfied' to 'very satisfied'. |
Countries
Denmark
Outcome results
None listed