A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With … (NCT07616921) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
United States30 participantsStarted 2026-07-01
Plain-language summary
This clinical trial studies how well a home-based exercise intervention called Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) works in improving heart function among patients with high risk acute myeloid leukemia (AML) undergoing stem cell transplant. Older adults and those with other medical conditions are at a higher risk for complications in the heart and blood vessels (cardiovascular). Older age at transplantation has been associated with nearly all cardiovascular complications occurring after stem cell transplant. This is likely explained by the structural and functional changes that occur in aging hearts as well as the larger burden of cardiovascular risk factors such as diabetes, high blood pressure, and obesity. CAREFit-BMT is a "prehabilitation" program, or exercise initiated prior to intensive therapy, that consists of aerobic exercises and strength training. CAREFit-BMT may be able to increase the likelihood of safe and successful transition to stem cell transplant in patients with high risk AML.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Ability to understand and willingness to sign a written informed consent document
* New diagnosis of acute myeloid leukemia at Fred Hutch
* High-risk patients as defined by one, or more, of the following criteria:
* Age 65 years or older and/or
* Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3 (for patients 20 years old or older) and/or
* CARE-BMT score ≥ 5
* Note: HCT-CI and CARE-BMT scores will be measured at pre-screening by study staff
* Able to exercise at low to moderate intensity, as evaluated by study staff
* Access to a mobile smart phone
* Able to read and write in English
Exclusion Criteria:
* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
* Recurrence of AML or diagnosis of other invasive cancer
* Severe anemia (hemoglobin \< 7 gm/dl)
* History of severe aortic stenosis
* New York Heart Association (NYHA) class IV heart failure
* Severe pain with basic movement
* Pregnant persons
* Unable to give consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment rates (Feasibility)
Timeframe: Up to 24 months
2
Retention rates (Feasibility)
Timeframe: Up to 24 months
3
Adherence to program (Feasibility)
Timeframe: At the end of the CAREFit-BMT program (Day 85)
4
Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score
Timeframe: At the end of the CAREFit-BMT program (Day 85)
5
Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score
Timeframe: At the end of the CAREFit-BMT program (Day 85)
6
Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score
Timeframe: At the end of the CAREFit-BMT program (Day 85)