NCT06299722

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	STEEL	Relatively heavy strength training
OTHER	Circuit training	Circuit training

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-09-12
• Completion: 2025-09-12
• First posted: 2024-03-08
• Last updated: 2026-01-08

Locations

4 sites across 1 country: Denmark