Clinical trial NCT06299722: Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Isometric strength
timeFrame: Baseline and at the 8-week and 16-week follow-ups
Secondary outcomes:
measure: Health-related quality of life
timeFrame: During baseline and at the 16-week follow-up
measure: Step counts
timeFrame: Weekly throughout the 16-week intervention
measure: Caloric expenditure
timeFrame: Weekly throughout the 16-week intervention
measure: Maximal dynamic strength
timeFrame: During the first and last training sessions of the 16-week intervention
measure: Bone mineral density of the lumbar spine and body composition
timeFrame: During baseline and at the 16-week follow-up
measure: Grip strength and rate of force development
timeFrame: Baseline and at the 8-week and 16-week follow-ups
measure: Muscular strength, endurance, and rate of force development
timeFrame: Baseline and at the 8-week and 16-week follow-ups
measure: Cardiorespiratory fitness and endurance
timeFrame: Baseline and at the 8-week and 16-week follow-ups
measure: Exercise compliance and fidelity
timeFrame: Throughout the 16-week intervention
measure: Adverse events
timeFrame: Throughout the 16-week intervention
measure: Movement-evoked pain
timeFrame: During baseline and at the 16-week follow-up
measure: Satisfaction with the intervention
timeFrame: During the 16-week follow-up
measure: Blood glucose
timeFrame: During baseline and at the 16-week follow-up
measure: Glycated hemoglobin (Hba1c)
timeFrame: During baseline and at the 16-week follow-up
measure: Insulin
timeFrame: During baseline and at the 16-week follow-up
measure: Proinsulin c-peptide
timeFrame: During baseline and at the 16-week follow-up
measure: Total cholesterol
timeFrame: During baseline and at the 16-week follow-up
measure: High-density lipoprotein cholesterol
timeFrame: During baseline and at the 16-week follow-up
measure: Low-density lipoprotein cholesterol
timeFrame: During baseline and at the 16-week follow-up
measure: Very low-density lipoprotein cholesterol
timeFrame: During baseline and at the 16-week follow-up
measure: Triglycerides
timeFrame: During baseline and at the 16-week follow-up
measure: Glucagon
timeFrame: During baseline and at the 16-week follow-up
measure: Homeostatic Model assessment for Insulin resistance score
timeFrame: During baseline and at the 16-week follow-up
measure: Body Mass Index (BMI)
timeFrame: During baseline and at the 16-week follow-up
measure: Lean body mass
timeFrame: During baseline and at the 16-week follow-up
measure: Fat mass
timeFrame: During baseline and at the 16-week follow-up
measure: Android/gynoid fat distribution
timeFrame: During baseline and at the 16-week follow-up
measure: Abdominal circumference
timeFrame: During baseline and at the 16-week follow-up
measure: Self-reported Tanner staging
timeFrame: During baseline and at the 16-week follow-up
measure: Blood pressure
timeFrame: During baseline and at the 16-week follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Gistrup
country: Denmark
facility: Aalborg University
city: Odense
country: Denmark
facility: Odense University Hospital
city: Århus
country: Denmark
facility: Århus University Hospital
Study officials:
affiliation: Aalborg University
name: Pascal Madeleine, DSc
role: STUDY_CHAIR
References: