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

Aalborg University

Status: Enrolling

Conditions: Cancer

Treatments: Other: Circuit training; Other: STEEL

Study type: Interventional

Funder types: Other

Identifiers

NCT06299722

N-20230055

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

STEEL

Experimental group

Description:

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.

Treatment:

Other: STEEL

Circuit training

Active Comparator group

Description:

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.

Treatment:

Other: Circuit training