Actively Recruiting
Feasibility and Safety of Exercise in Patients With Low-risk (or Early-stage) Myeloid Cancers and Precursor Conditions (HemEx): a Randomized Controlled Pilot Trial
Led by Rigshospitalet, Denmark · Updated on 2025-08-19
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how exercise might affect people with low-risk myeloid cancers or precursor conditions such as Clonal Cytopenia of Undetermined Significance (CCUS) and early-stage Myelodysplastic Syndrome (MDS). These conditions can lead to serious blood cancers like acute myeloid leukemia (AML) over time, especially in older adults. The study aims to explore if exercise can alter the bone marrow environment to delay or prevent disease progression, improve quality of life, and assess the feasibility and safety of such interventions. Participants will be randomly assigned to either continue their usual care or engage in a high-intensity interval exercise program totaling 180 minutes per week. This includes 12 weeks of supervised exercise followed by 12 weeks of non-supervised exercise. The trial is designed as a pilot to evaluate the practical aspects of conducting exercise interventions in this patient group and to observe potential biological and clinical effects. During the study, participants' attendance at exercise sessions, recruitment and retention rates, and any adverse events will be closely monitored over 24 weeks. Various health measures will be assessed, including aerobic capacity, muscle strength, body composition, blood biochemistry, immune markers, and patient-reported symptoms, at baseline, after the supervised exercise period, and after the non-supervised phase. These evaluations will help understand how exercise impacts disease-related factors and daily functioning in this population.
CONDITIONS
Brief Title
Feasibility and Safety of Exercise in Patients With Low-risk Myeloid Cancers and Precursor Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lower-risk Myelodysplastic Syndrome or Clonal Cytopenia of Undetermined Significance (WHO 2022 Classification)
- Written informed consent prior to study procedures
- Performance status of 2 or less
- Age over 18 years
You will not qualify if you...
- Unable to perform exercise due to physical disabilities or conditions such as arthrosis
- Regularly exercising at moderate or high levels (not scoring "low" on physical activity questionnaire)
- Unwilling to participate in the exercise intervention
- Current use of metformin
- Received chemotherapy, therapeutic radiation, or immunosuppressive therapy within the past year
- Treatment with hypomethylating agents
- Any absolute contraindication to cardiopulmonary exercise testing per American Heart Association and Danish Society of Cardiology guidelines
- Hemoglobin levels below 5.5 mmol, or below 6.5 mmol with cardiac insufficiency or pacemaker
- Dependent on 8 or more units of red blood cell transfusion in 16 weeks
- Uncontrolled co-morbid medical conditions
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants complete weekly supervised exercise sessions for 12 weeks followed by 12 weeks of non-supervised exercise to assess feasibility and safety.
Weekly supervised exercise sessions for 12 weeks followed by non-supervised exercise for 12 weeks
Trial Site Locations
Total: 2 locations
1
Rigshospitalet
Copenhagen, Denmark, Denmark, 2100
Not Yet Recruiting
2
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
K
Kirsten Gørnbæk, Professor
S
Stine Bitsch-Olsen, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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