CancerSTEELNCT06299722
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents
A study testing STEEL and Circuit training in people with Cancer, run by Aalborg University at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Cancer
- What is being tested?
- STEEL and Circuit training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesDenmark
- Study dates
- 26 Apr 2024to 12 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Denmark4 sites
Århus University Hospital
Aarhus
Rigshospitalet
Copenhagen
Aalborg University
Gistrup, 9260
Odense University Hospital
Odense
About this study
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
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).
Read the 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
- Being tested
- STEEL, Circuit training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEELOther
Relatively heavy strength training
Circuit trainingOther
Circuit training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric strength
Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry
Measured: Baseline and at the 8-week and 16-week follow-ups
Secondary outcomes (30)
Health-related quality of life
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
Measured: During baseline and at the 16-week follow-up
Step counts
We will assess participants' step counts throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).
Measured: Weekly throughout the 16-week intervention
Caloric expenditure
We will assess participants' caloric expenditure (KCAL) throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).
Measured: Weekly throughout the 16-week intervention
Maximal dynamic strength
we will test the 1 repetition maximum (RM) in the leg press and chest press machines
Measured: During the first and last training sessions of the 16-week intervention
Bone mineral density of the lumbar spine and body composition
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.
Measured: During baseline and at the 16-week follow-up
Grip strength and rate of force development
Using a digital hand dynamometer, we will measure continuous isometric handgrip force and rate of force development.
Measured: Baseline and at the 8-week and 16-week follow-ups
Muscular strength, endurance, and rate of force development
We will use a 30-second sit-to-stand test to evaluate strength, endurance, and rate of force development of the lower extremities.
Measured: Baseline and at the 8-week and 16-week follow-ups
Cardiorespiratory fitness and endurance
We will perform a 6-minute walk test to evaluate cardiorespiratory fitness and walking endurance
Measured: Baseline and at the 8-week and 16-week follow-ups
Exercise compliance and fidelity
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.
Measured: Throughout the 16-week intervention
Adverse events
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.
Measured: Throughout the 16-week intervention
Movement-evoked pain
We will use a 0 (no pain) to 10 (worst pain imaginable) Numerical Rating Scale to assess movement-evoked pain during the past week
Measured: During baseline and at the 16-week follow-up
Satisfaction with the intervention
We will assess participant satisfaction with their respective intervention using a 5-point rank scale ranging from 'very dissatisfied' to 'very satisfied'.
Measured: During the 16-week follow-up
Blood glucose
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
Glycated hemoglobin (Hba1c)
Analysed from a blood sample and measured in mmol/mol
Measured: During baseline and at the 16-week follow-up
Insulin
Analysed from a blood sample and measured in mU/L
Measured: During baseline and at the 16-week follow-up
Proinsulin c-peptide
Analysed from a blood sample and measured in ng/mL
Measured: During baseline and at the 16-week follow-up
Total cholesterol
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
High-density lipoprotein cholesterol
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
Low-density lipoprotein cholesterol
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
Very low-density lipoprotein cholesterol
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
Triglycerides
Analysed from a blood sample and measured in mmol/L
Measured: During baseline and at the 16-week follow-up
Glucagon
Analysed from a blood sample and measured in pg/mL
Measured: During baseline and at the 16-week follow-up
Homeostatic Model assessment for Insulin resistance score
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)
Measured: During baseline and at the 16-week follow-up
Body Mass Index (BMI)
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.
Measured: During baseline and at the 16-week follow-up
Lean body mass
Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)
Measured: During baseline and at the 16-week follow-up
Fat mass
Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)
Measured: During baseline and at the 16-week follow-up
Android/gynoid fat distribution
Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) adjusted for sex and pubertal stage
Measured: During baseline and at the 16-week follow-up
Abdominal circumference
Measured in centimetres
Measured: During baseline and at the 16-week follow-up
Self-reported Tanner staging
Visual illustration of Tanner staging (I-V) regarding both genders
Measured: During baseline and at the 16-week follow-up
Blood pressure
Measured in mmHg
Measured: During baseline and at the 16-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start26 Apr 2024
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Riel, Aalborg University
- Investigators
- Pascal Madeleine, DSc, Study chair, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299722
- Sponsor's protocol ID
- N-20230055
- Acronym
- STEEL
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06299722
- Acronym / sponsor ID
- STEEL / N-20230055
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEEL | Experimental | Other: STEELSTEEL 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. |
| Circuit training | Active comparator | Other: Circuit trainingThere 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEELRelatively heavy strength training | Other | STEEL |
| Circuit trainingCircuit training | Other | Circuit training |
Primary outcome
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
30 secondary outcomes
Health-related quality of life
Time frame: During baseline and at the 16-week follow-up
Step counts
Time frame: Weekly throughout the 16-week intervention
Caloric expenditure
Time frame: Weekly throughout the 16-week intervention
Maximal dynamic strength
Time frame: 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
Grip strength and rate of force development
Time frame: 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
Cardiorespiratory fitness and endurance
Time frame: Baseline and at the 8-week and 16-week follow-ups
Exercise compliance and fidelity
Time frame: Throughout the 16-week intervention
Adverse events
Time frame: Throughout the 16-week intervention
Movement-evoked pain
Time frame: During baseline and at the 16-week follow-up
Satisfaction with the intervention
Time frame: During the 16-week follow-up
Blood glucose
Time frame: During baseline and at the 16-week follow-up
Glycated hemoglobin (Hba1c)
Time frame: During baseline and at the 16-week follow-up
Insulin
Time frame: During baseline and at the 16-week follow-up
Proinsulin c-peptide
Time frame: During baseline and at the 16-week follow-up
Total cholesterol
Time frame: During baseline and at the 16-week follow-up
High-density lipoprotein cholesterol
Time frame: During baseline and at the 16-week follow-up
Low-density lipoprotein cholesterol
Time frame: 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
Triglycerides
Time frame: During baseline and at the 16-week follow-up
Glucagon
Time frame: 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
Body Mass Index (BMI)
Time frame: During baseline and at the 16-week follow-up
Lean body mass
Time frame: During baseline and at the 16-week follow-up
Fat mass
Time frame: During baseline and at the 16-week follow-up
Android/gynoid fat distribution
Time frame: During baseline and at the 16-week follow-up
Abdominal circumference
Time frame: During baseline and at the 16-week follow-up
Self-reported Tanner staging
Time frame: During baseline and at the 16-week follow-up
Blood pressure
Time frame: During baseline and at the 16-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Madeleine, DSc study chair
Aalborg University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEEL and Circuit training in people with Cancer, run by Aalborg University at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric strength (time frame: Baseline and at the 8-week and 16-week follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.