RecruitingRecruiting
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
NCT07616921 · University of Washington
In plain English
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Official title
CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation
About this study
OUTLINE:
Patients undergo at-home moderate-intensity aerobic exercises over 30 minutes, 5 days per week, as well as strength training over 15-30 minutes, 3 days per week for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of the study intervention, patients are followed for 12 months.
Eligibility 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
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-10-15
Estimated completion: 2028-04-03
Last updated: 2026-09-11
Interventions
Other: Aerobic ExerciseOther: Resistance TrainingProcedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: Survey AdministrationOther: Interview
Primary outcomes
- • Recruitment rates (Feasibility) (Up to 24 months)
- • Retention rates (Feasibility) (Up to 24 months)
- • Adherence to program (Feasibility) (At the end of the CAREFit-BMT program (Day 85))
Sponsor
University of Washington · other
With: National Center for Advancing Translational Sciences (NCATS)
Contacts & investigators
ContactAlexi Vasbinder, PhD, RN · contact · avasbind@uw.edu · 206-221-4390
InvestigatorAlexi Vasbinder, PhD, RN · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (1)
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States