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

NCT06299722 | Completed

• 1 other identifier: N-20230055
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Isometric strength

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

  Baseline and at the 8-week and 16-week follow-ups

Secondary Outcomes (30)

• Health-related quality of life

  During baseline and at the 16-week follow-up

• Step counts

  Weekly throughout the 16-week intervention

• Caloric expenditure

  Weekly throughout the 16-week intervention

• Maximal dynamic strength

  During the first and last training sessions of the 16-week intervention

• Bone mineral density of the lumbar spine and body composition

  During baseline and at the 16-week follow-up

Study Arms (2)

STEEL

EXPERIMENTAL

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.

Other: STEEL

Circuit training

ACTIVE COMPARATOR

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.

Other: Circuit training

Interventions

STEEL OTHER

Relatively heavy strength training

STEEL

Circuit training OTHER

Circuit training

Circuit training

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A minimum of 12 months since the last chemotherapy with no upper limit
• Ability to understand the physical intervention and general participant advice

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (4)

Århus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Aalborg University

Gistrup, 9260, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Steel; Circuit-Based Exercise

Intervention Hierarchy (Ancestors)

Iron Compounds; Inorganic Chemicals; Alloys; Metals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pascal Madeleine, DSc

  Aalborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 8, 2024
• Study Start: April 26, 2024
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (4)