Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedDecember 1, 2026
Main results expectedApril 3, 2028
Study endsApril 3, 2028
Registry record updatedOctober 29, 2026
Trial IDNCT07616921 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.