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

January 6, 2026 updated by: Henrik Riel, Aalborg University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Århus University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
      • Gistrup, Denmark, 9260
        • Aalborg University
      • Odense, Denmark
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STEEL
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
Relatively heavy strength training
Active Comparator: Circuit training
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
Circuit training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isometric strength
Time Frame: 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
Baseline and at the 8-week and 16-week follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 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
During baseline and at the 16-week follow-up
Step counts
Time Frame: 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).
Weekly throughout the 16-week intervention
Caloric expenditure
Time Frame: 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).
Weekly throughout the 16-week intervention
Maximal dynamic strength
Time Frame: 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
During the first and last training sessions of the 16-week intervention
Bone mineral density of the lumbar spine and body composition
Time Frame: 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.
During baseline and at the 16-week follow-up
Grip strength and rate of force development
Time Frame: 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.
Baseline and at the 8-week and 16-week follow-ups
Muscular strength, endurance, and rate of force development
Time Frame: 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.
Baseline and at the 8-week and 16-week follow-ups
Cardiorespiratory fitness and endurance
Time Frame: 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
Baseline and at the 8-week and 16-week follow-ups
Exercise compliance and fidelity
Time Frame: 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.
Throughout the 16-week intervention
Adverse events
Time Frame: 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.
Throughout the 16-week intervention
Movement-evoked pain
Time Frame: 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
During baseline and at the 16-week follow-up
Satisfaction with the intervention
Time Frame: 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'.
During the 16-week follow-up
Blood glucose
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
Glycated hemoglobin (Hba1c)
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/mol
During baseline and at the 16-week follow-up
Insulin
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mU/L
During baseline and at the 16-week follow-up
Proinsulin c-peptide
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in ng/mL
During baseline and at the 16-week follow-up
Total cholesterol
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
High-density lipoprotein cholesterol
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
Low-density lipoprotein cholesterol
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
Very low-density lipoprotein cholesterol
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
Triglycerides
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in mmol/L
During baseline and at the 16-week follow-up
Glucagon
Time Frame: During baseline and at the 16-week follow-up
Analysed from a blood sample and measured in pg/mL
During baseline and at the 16-week follow-up
Homeostatic Model assessment for Insulin resistance score
Time Frame: 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)
During baseline and at the 16-week follow-up
Body Mass Index (BMI)
Time Frame: 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.
During baseline and at the 16-week follow-up
Lean body mass
Time Frame: During baseline and at the 16-week follow-up
Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)
During baseline and at the 16-week follow-up
Fat mass
Time Frame: During baseline and at the 16-week follow-up
Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)
During baseline and at the 16-week follow-up
Android/gynoid fat distribution
Time Frame: 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
During baseline and at the 16-week follow-up
Abdominal circumference
Time Frame: During baseline and at the 16-week follow-up
Measured in centimetres
During baseline and at the 16-week follow-up
Self-reported Tanner staging
Time Frame: During baseline and at the 16-week follow-up
Visual illustration of Tanner staging (I-V) regarding both genders
During baseline and at the 16-week follow-up
Blood pressure
Time Frame: During baseline and at the 16-week follow-up
Measured in mmHg
During baseline and at the 16-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pascal Madeleine, DSc, Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20230055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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