Stem Cell TransplantSTEPSNCT04922970
Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.
A study testing Strength training in people with Stem Cell Transplant and Late Effect, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplant, Late Effect, Metabolic Syndrome
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2021to 24 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
- ≥ 18 years old
Who cannot join
- Illness or physical handicap making it impossible to participate in the training intervention
- Pregnancy
- Not Danish or English speaking
- Anemia
- Already performing regular structured physical training
- Strict vegan or vegetarian diet
- Illness or ongoing treatment that hinders study examinations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital Copenhagen - Rigshospitalet
Copenhagen, 2100
About this study
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.
In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.
Read more
Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.
The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.
If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.
- Being tested
- Strength training
- Keywords
- Strength training, Resistance training
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | In this arm participants will go through the "Strength training intervention". Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cross sectional area of m. quadricpes femoris.
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
Measured: 1 week pre intervention
Changes in cross sectional area of m. quadricpes femoris.
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
Measured: 1 week post intervention
Secondary outcomes (26)
Changes in components of the Metabolic Syndrome: Waist circumference
Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Waist circumference
Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week post intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week post intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week pre intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week post intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week post intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
Measured: 1 week post intervention
Hip circumference
Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
Measured: 1 week pre intervention
Hip circumference
Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
Measured: 1 week post intervention
Urine sample - microalbuminurea
A urine sample for analyses of microalbuminurea in mg/L.
Measured: 1 week pre intervention
Urine sample - microalbuminurea
A urine sample for analyses of microalbuminurea in mg/L.
Measured: 1 week post intervention
Muscle strength of quadriceps femoris
Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
Measured: 1 week pre intervention
Muscle strength of quadriceps femoris
Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
Measured: 1 week post intervention
Handgrip strength
Handgrip strength measured with handheld Dynamometer
Measured: 1 week pre intervention
Handgrip strength
Handgrip strength measured with handheld Dynamometer
Measured: 1 week post intervention
Muscle performance: Timed-up-and-go
Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.
Measured: 1 week pre intervention
Muscle performance: Timed-up-and-go
Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.
Measured: 1 week post intervention
Muscle performance: Sit-to-stand 30 sec.
Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
Measured: 1 week pre intervention
Muscle performance: Sit-to-stand 30 sec.
Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
Measured: 1 week post intervention
Muscle performance: Sit-to-stand 60 sec.
Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
Measured: 1 week pre intervention
Muscle performance: Sit-to-stand 60 sec.
Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
Measured: 1 week post intervention
Cardiorespiratory fitness: 6 minute walk test
6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.
Measured: 1 week pre intervention
Cardiorespiratory fitness: 6 minute walk test
6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.
Measured: 1 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start8 Sep 2021
- Primary completion21 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The same interventon will be applied to two groups, a group of previously recipients of bone marrow transplantation, and a group of age- and sex-matched controls.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Danish Child Cancer Foundation, University of Copenhagen, The Danish Cancer Research Foundation
- Responsible party
- Principal investigator, Klaus Gottlob Müller, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922970
- Sponsor's protocol ID
- STEPS
- Acronym
- STEPS
- Status last verified
- May 2026
- First submitted
- 4 Jun 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krogh LM, Nissen A, Weischendorff S, Hartmann B, Andersen JL, Holst JJ, Sorensen K, Fridh MK, Mackey AL, Muller K. Bone remodeling in survivors of pediatric hematopoietic stem cell transplantation: Impact of heavy resistance training. Pediatr Blood Cancer. 2024 Sep;71(9):e31159. doi: 10.1002/pbc.31159. Epub 2024 Jul 2.
PubMed 38953152
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.
- ClinicalTrials.gov ID
- NCT04922970
- Acronym / sponsor ID
- STEPS / STEPS
- Keywords
- Strength training, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Danish Child Cancer Foundation, University of Copenhagen, The Danish Cancer Research Foundation
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 11 Jun 2021 (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.
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.
In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.
Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.
The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.
If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The same interventon will be applied to two groups, a group of previously recipients of bone marrow transplantation, and a group of age- and sex-matched controls.
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength trainingIn this arm participants will go through the "Strength training intervention". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
- ≥ 18 years old
Key exclusion criteria (7 listed)
- Illness or physical handicap making it impossible to participate in the training intervention
- Pregnancy
- Not Danish or English speaking
- Anemia
- Already performing regular structured physical training
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 |
|---|---|---|
| Strength trainingThe interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months. | Other | Strength training |
Primary outcome
Changes in cross sectional area of m. quadricpes femoris.
Time frame: 1 week pre intervention
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
Changes in cross sectional area of m. quadricpes femoris.
Time frame: 1 week post intervention
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
26 secondary outcomes
Changes in components of the Metabolic Syndrome: Waist circumference
Time frame: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Waist circumference
Time frame: 1 week post intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Time frame: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Time frame: 1 week post intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time frame: 1 week pre intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time frame: 1 week post intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Time frame: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Time frame: 1 week post intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Time frame: 1 week pre intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Time frame: 1 week post intervention
Hip circumference
Time frame: 1 week pre intervention
Hip circumference
Time frame: 1 week post intervention
Urine sample - microalbuminurea
Time frame: 1 week pre intervention
Urine sample - microalbuminurea
Time frame: 1 week post intervention
Muscle strength of quadriceps femoris
Time frame: 1 week pre intervention
Muscle strength of quadriceps femoris
Time frame: 1 week post intervention
Handgrip strength
Time frame: 1 week pre intervention
Handgrip strength
Time frame: 1 week post intervention
Muscle performance: Timed-up-and-go
Time frame: 1 week pre intervention
Muscle performance: Timed-up-and-go
Time frame: 1 week post intervention
Muscle performance: Sit-to-stand 30 sec.
Time frame: 1 week pre intervention
Muscle performance: Sit-to-stand 30 sec.
Time frame: 1 week post intervention
Muscle performance: Sit-to-stand 60 sec.
Time frame: 1 week pre intervention
Muscle performance: Sit-to-stand 60 sec.
Time frame: 1 week post intervention
Cardiorespiratory fitness: 6 minute walk test
Time frame: 1 week pre intervention
Cardiorespiratory fitness: 6 minute walk test
Time frame: 1 week post intervention
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 11 May 2026.
- Derived from this study: PubMed 38953152Krogh LM, Nissen A, Weischendorff S, Hartmann B, Andersen JL, Holst JJ, Sorensen K, Fridh MK, Mackey AL, Muller K. Bone remodeling in survivors of pediatric hematopoietic stem cell transplantation: Impact of heavy resistance training. Pediatr Blood Cancer. 2024 Sep;71(9):e31159. doi: 10.1002/pbc.31159. Epub 2024 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Stem Cell Transplant and Late Effect, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 2 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in cross sectional area of m. quadricpes femoris. (time frame: 1 week pre intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922970, which also lists 1 linked publication.
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 11 May 2026.