Home-based heart fitness program for high-risk AML patients undergoing stem cell transplant
Official title: CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation
Run by University of Washington · NCT07616921 · Data updated 2026-11-12
A home-based exercise program called CAREFit-BMT is being tested to see if it can improve heart function in adults with high-risk acute myeloid leukemia who are getting a stem cell transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | December 1, 2026 |
| Main results expected | April 3, 2028 |
| Study ends | April 3, 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07616921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with newly diagnosed high-risk AML at Fred Hutch who are planning stem cell transplantation and can safely participate in low-to-moderate intensity exercise.
✕Probably not a fit
Patients who cannot safely perform even low-to-moderate intensity exercise or who do not meet eligibility criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests whether a structured, home-based program combining aerobic exercise and resistance training can support heart health in patients with high-risk AML undergoing transplantation. Participants perform 30 minutes of moderate aerobic activity five days a week and 15–30 minutes of strength training three days a week for up to 12 weeks, with safety monitoring and blood tests during the study. After the intervention, they are followed for 12 months to observe outcomes. The program is designed as prehabilitation to help patients better tolerate intensive therapy and reduce cardiovascular risks.
Why it matters
Potential benefit: If successful, CAREFit-BMT could improve heart function and potentially reduce transplant-related cardiovascular complications.
How similar studies have gone: Previous work suggests exercise programs around cancer treatment can improve physical fitness, but this exact home-based prehabilitation approach in high-risk AML patients undergoing transplant is a novel/limited area.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Alexi Vasbinder, PhD, RN — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Alexi Vasbinder, PhD, RN
- Email: avasbind@uw.edu
- Phone: 206-221-4390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.