Myelodysplastic SyndromeHemExNCT06773871
Feasibility and Safety of Exercise in Patients With Low-risk Myeloid Cancers and Precursor Conditions
A study testing Exercise in people with Myelodysplastic Syndrome and Cytopenia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Somatic mutations as seen in myeloid malignancies can also be detected in healthy, elderly individuals (clonal hematopoiesis of indeterminate potential, CHIP), in patients with unex-plained cytopenia, that do not fulfill the criteria for myeloid malignancy (clonal cytopenia of un-determined significance, CCUS) It has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Cytopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Mar 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of either Lower-risk of Myelodysplastic Syndrome or Clonal Cytopenia of undetermined significance(WHO 2022 Classification)
- Written informed consent prior to study procedures
- Performance status ≤ 2
- Age > 18 years old
Who cannot join
- Physically not able to undergo exercise intervention (e.g., arthrosis, physical disabilities)
- Exercising on a regular basis (i.e., participants must score in the category "low" when screening with International Physical Activity Questionnaire-Short Form; IPAQ-SF27)
- Unwillingness to undergo exercise intervention
- Use of metformin
- Treatment with chemotherapy, therapeutic radiation, or immunosuppressive therapy within the last year
- Treatment with hypomethylating agents
Show all 10Show fewer
- Any absolute contraindication to undergo cardiopulmonary exercise testing according to working papers from American Heart Association and Danish Society of Cardiology
- Hemoglobin levels < 5.5 mmol OR <6.5 mmol and simultaneous cardiac insufficiency OR pacemaker.
- Blood transfusion-dependent ≥ 8 units of red blood cell transfusion in 16 weeks (IWG 2018-criteria)
- Uncontrolled co-morbidity
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Stine Bitsch-Olsen, MSc contact
Denmark2 sites, 2 recruiting
- Not yet recruiting
Rigshospitalet
Copenhagen, Denmark, 2100
Kirsten Grønbæk, Professor, +44535456086, kirsten.groenbaek@regionh.dk
Stine Bitsch-Olsen, MSc, stine.bitsch-olsen@regionh.dk
- Recruiting
Rigshospitalet
Copenhagen
About this study
Official title: Feasibility and Safety of Exercise in Patients With Low-risk (or Early-stage) Myeloid Cancers and Precursor Conditions (HemEx): a Randomized Controlled Pilot Trial
Somatic mutations as seen in myeloid malignancies can also be detected in healthy, elderly individuals (clonal hematopoiesis of indeterminate potential, CHIP), in patients with unex-plained cytopenia, that do not fulfill the criteria for myeloid malignancy (clonal cytopenia of un-determined significance, CCUS) It has been shown that these conditions predispose to hema-tological cancer. For patients with CCUS, it has been reported that in a 5-year period up to 50-90 % of the patients will progress to myelodysplastic syndrome (MDS) or acute myeloid leu-kemia (AML), both devastating diseases with poor outcomes, especially for the elderly popula-tion. There is currently no treatment available for patients with CCUS besides supporting agents. Since the somatic mutations can be detected up to 10 years before a diagnosis of MDS, it opens the potential for early intervention.
Physical inactivity is associated with multiple solid cancers, and it has been suggested that exercise can prevent for example certain colon- or breast cancers. Studies in mice have shown that exercise can reduce tumor size and incidence of solid cancers, and different mechanisms have been suggested including increased immune cell infiltration, reduced systemic inflamma-tion, and metabolic changes. The mechanisms of disease progression of pre-leukemia and MDS are complex and probably multifactorial, but recent studies suggest that components such as natural killer cells, adipocytes, and inflammatory substances in the bone marrow mi-croenvironment play a crucial role; factors that exercise may modulate. In addition, recent stud-ies have shown that increased bone marrow adipose tissue (BMAT) may create a microenvi-ronment that supports the expansion of leukemic cells and thus may facilitate disease progres-sion, and earlier studies among healthy, younger individuals have shown that exercise can reduce the amount of BMAT significantly.
Read more
Therefore, the investigators hypothesize that exercise may prevent or delay the progression from pre-leukemia to leukemia by altering the microenvironment in the bone marrow.
The purpose with this clinical, pilot trial where patients with the preleukemic condition CCUS or early stage of leukemia (i.e., lower-risk MDS) will undergo an individualized exercise interven-tion, is to investigate:
- whether an exercise intervention and the trial set-up, are feasible and safe in this cohort,
- potential mechanisms in leukemogenesis affected by exercise in controlling dis-ease progression,
- and the effect hereof on quality of life and activities of daily living. The above will inform the decision-making on designing a larger randomized, controlled trial.
- Conditions
- Myelodysplastic Syndrome, Cytopenia
- Being tested
- Exercise, Control
- Medical subject headings
- Myelodysplastic Syndromes, Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Weekly supervised exercise for 12 weeks followed by 12 weeks of non-supervised exercise
ControlOther
Remain usual activity level
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Usual care Receives: Other: Control |
| Exercise intervention | Experimental | High-intensity interval exercise (180 min/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise feasibility: Exercise sessions attendance
The number of attended exercise training sessions relative to the number of planned exercise sessions
Measured: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Exercise feasibility: Recruitment, refusal, and retention rates
The number of patients recruited to the study, the number of patients who refused to be enrolled in the study, the number of participants that completed the study
Measured: From baseline until end of intervention (24 weeks)
Incidence of Adverse Events (AEs)
AE will be recorded during trial assessment visits and through medical records. This procedure will concern any AE during the trial period. We will collect patients' self-report of AEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.
Measured: From baseline until the end of intervention (24 weeks)
Incidence of Serious Adverse Events (SAEs)
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. We will collect patients' self-report of SAEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.
Measured: From baseline until the end of intervention (24 weeks)
Secondary outcomes (31)
Changes in peak oxygen consumption (VO2 peak)
Changes in VO2peak assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer
Measured: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Aerobic Capacity: Peak power output
Changes in peak power output assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer
Measured: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Muscle strength: Hand grip strength
Changes in hand grip strength, assessed using a dynamometer
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Functional performance: Habitual gait speed
Changes in habitual gait speed
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Functional performance: 30 seconds Sit-to-stand
Changes in the number of stands from sitting position that can be performed during 30 seconds
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Body mass
Changes in body mass
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Total lean mass
Changes in total lean mass assessed by dual energy x-ray absorptiometry (DXA)
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Total fat mass
Changes in total fat mass assessed by DXA
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Bone mineral density
Changes in bone mineral density assessed by DXA
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: C-reactive protein
Changes in resting C-reactive protein levels in blood
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Insulin
Changes in resting insulin blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Glucose
Changes in resting glucose blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Triglycerides
Changes in resting triglycerides blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: LDL-Cholesterol
Changes in resting LDL-cholesterol blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: HDL-Cholesterol
Changes in resting HDL-cholesterol blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Total Cholesterol
Changes in resting Cholesterol blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: HbA1c
Changes in resting HbA1c blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: total bilirubin
Changes in resting total bilirubin blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Vitamin D (25-Hydroxy-Vitamin D(D3+D2))
Changes in resting Vitamin D (25-Hydroxy-Vitamin D(D3+D2)) blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: insulin growth factor 1 (IGF-1)
Changes in resting insulin growth factor 1 (IGF-1) blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: human growth hormone (HGH)
Changes in resting human growth hormone (HGH) blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: sex hormones (estrogen, progesterone and testosterone)
Changes in resting human sex hormones (estrogen, progesterone and testosterone)blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Cytokine levels in blood: Interleukin-6
Changes in resting Interleukin-6 blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha)
Changes in resting TNFalpha blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Patient-reported symptomatic adverse events
Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Inflammatory markers in Bone marrow (BM) and peripheral blood
Changes in the inflammatory markers INF-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, adiponectin and leptin in bone marrow aspirate and peripheral blood
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Regulate the immune cell composition in the BM
Changes in immune cell composition in the BM measured by flow cytometry
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Change the variant allele frequency (VAF)
Changes in VAF detected with targeted next generation sequencing (NGS)
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Alter the composition of BMAT
Changes in BMAT composition
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Ifluence on the cytopenia(s)
Changes in blood cell counts (i.e., hemoglobin, white blood cell count, platelet count, absolute neutrophil count, lymphocyte count, basophil count, eosinophil count, monocyte count, reticulocyte count, peripheral blood blast count, red cell)
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Lactate dehydrogenase (LDH)
Changes in resting Lactate dehydrogenase (LDH) blood levels
Measured: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start10 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Grønbæk, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773871
- Sponsor's protocol ID
- H-23022425
- Acronym
- HemEx
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Exercise in Patients With Low-risk (or Early-stage) Myeloid Cancers and Precursor Conditions (HemEx): a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06773871
- Acronym / sponsor ID
- HemEx / H-23022425
- Conditions
- Myelodysplastic Syndrome, Cytopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jan 2025 (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.
Somatic mutations as seen in myeloid malignancies can also be detected in healthy, elderly individuals (clonal hematopoiesis of indeterminate potential, CHIP), in patients with unex-plained cytopenia, that do not fulfill the criteria for myeloid malignancy (clonal cytopenia of un-determined significance, CCUS) It has been shown that these conditions predispose to hema-tological cancer. For patients with CCUS, it has been reported that in a 5-year period up to 50-90 % of the patients will progress to myelodysplastic syndrome (MDS) or acute myeloid leu-kemia (AML), both devastating diseases with poor outcomes, especially for the elderly popula-tion. There is currently no treatment available for patients with CCUS besides supporting agents. Since the somatic mutations can be detected up to 10 years before a diagnosis of MDS, it opens the potential for early intervention.
Physical inactivity is associated with multiple solid cancers, and it has been suggested that exercise can prevent for example certain colon- or breast cancers. Studies in mice have shown that exercise can reduce tumor size and incidence of solid cancers, and different mechanisms have been suggested including increased immune cell infiltration, reduced systemic inflamma-tion, and metabolic changes. The mechanisms of disease progression of pre-leukemia and MDS are complex and probably multifactorial, but recent studies suggest that components such as natural killer cells, adipocytes, and inflammatory substances in the bone marrow mi-croenvironment play a crucial role; factors that exercise may modulate. In addition, recent stud-ies have shown that increased bone marrow adipose tissue (BMAT) may create a microenvi-ronment that supports the expansion of leukemic cells and thus may facilitate disease progres-sion, and earlier studies among healthy, younger individuals have shown that exercise can reduce the amount of BMAT significantly.
Therefore, the investigators hypothesize that exercise may prevent or delay the progression from pre-leukemia to leukemia by altering the microenvironment in the bone marrow.
The purpose with this clinical, pilot trial where patients with the preleukemic condition CCUS or early stage of leukemia (i.e., lower-risk MDS) will undergo an individualized exercise interven-tion, is to investigate:
- whether an exercise intervention and the trial set-up, are feasible and safe in this cohort,
- potential mechanisms in leukemogenesis affected by exercise in controlling dis-ease progression,
- and the effect hereof on quality of life and activities of daily living. The above will inform the decision-making on designing a larger randomized, controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlUsual care |
| Exercise intervention | Experimental | –High-intensity interval exercise (180 min/week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of either Lower-risk of Myelodysplastic Syndrome or Clonal Cytopenia of undetermined significance(WHO 2022 Classification)
- Written informed consent prior to study procedures
- Performance status ≤ 2
- Age > 18 years old
Key exclusion criteria (10 listed)
- Physically not able to undergo exercise intervention (e.g., arthrosis, physical disabilities)
- Exercising on a regular basis (i.e., participants must score in the category "low" when screening with International Physical Activity Questionnaire-Short Form; IPAQ-SF27)
- Unwillingness to undergo exercise intervention
- Use of metformin
- Treatment with chemotherapy, therapeutic radiation, or immunosuppressive therapy within the last year
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 |
|---|---|---|
| ExerciseWeekly supervised exercise for 12 weeks followed by 12 weeks of non-supervised exercise | Other | – |
| ControlRemain usual activity level | Other | Control |
Primary outcome
Exercise feasibility: Exercise sessions attendance
Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
The number of attended exercise training sessions relative to the number of planned exercise sessions
Exercise feasibility: Recruitment, refusal, and retention rates
Time frame: From baseline until end of intervention (24 weeks)
The number of patients recruited to the study, the number of patients who refused to be enrolled in the study, the number of participants that completed the study
Incidence of Adverse Events (AEs)
Time frame: From baseline until the end of intervention (24 weeks)
AE will be recorded during trial assessment visits and through medical records. This procedure will concern any AE during the trial period. We will collect patients' self-report of AEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.
Incidence of Serious Adverse Events (SAEs)
Time frame: From baseline until the end of intervention (24 weeks)
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. We will collect patients' self-report of SAEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.
31 secondary outcomes
Changes in peak oxygen consumption (VO2 peak)
Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Aerobic Capacity: Peak power output
Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Muscle strength: Hand grip strength
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Functional performance: Habitual gait speed
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Functional performance: 30 seconds Sit-to-stand
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Body mass
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Total lean mass
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Total fat mass
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Body composition and anthropometrics: Bone mineral density
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: C-reactive protein
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Insulin
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Glucose
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Triglycerides
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: LDL-Cholesterol
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: HDL-Cholesterol
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Total Cholesterol
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: HbA1c
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: total bilirubin
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Vitamin D (25-Hydroxy-Vitamin D(D3+D2))
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: insulin growth factor 1 (IGF-1)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: human growth hormone (HGH)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: sex hormones (estrogen, progesterone and testosterone)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Cytokine levels in blood: Interleukin-6
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Patient-reported symptomatic adverse events
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Inflammatory markers in Bone marrow (BM) and peripheral blood
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Regulate the immune cell composition in the BM
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Change the variant allele frequency (VAF)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Alter the composition of BMAT
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Ifluence on the cytopenia(s)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Changes in Blood biochemistry: Lactate dehydrogenase (LDH)
Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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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.
Stine Bitsch-Olsen, MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Myelodysplastic Syndrome and Cytopenia, run by Copenhagen University Hospital, Rigshospitalet at 2 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Gørnbæk, Professor (+4535456086, kirsten.groenbaek@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise feasibility: Exercise sessions attendance (time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.). The study lists 4 primary outcomes in all. 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 19 Aug 2025.