Recruiting

CAREFit-BMT

Sponsor:

University of Washington

Code:

NCT07616921

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Resistance Training

Biospecimen Collection

Electronic Health Record Review

Survey Administration

Study Details

Brief 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.

Conditions

Acute Myeloid Leukemia

Study ID

NCT07616921

Start date

Oct 15, 2026

Status verified date

May, 2026

Completion date

Apr 3, 2028

Anticipated

Primary completion date

Apr 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (CAREFit-BMT exercise program)

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.

Interventions

Aerobic Exercise

Undergo moderate-intensity aerobic exercises

Resistance Training

Undergo strength training

Biospecimen Collection

Undergo collection of blood

Electronic Health Record Review

Ancillary studies

Survey Administration

Ancillary studies

Interview

Ancillary studies

Primary outcome measure

  • Recruitment rates (Feasibility) [ Time Frame: Up to 24 months ]
  • Retention rates (Feasibility) [ Time Frame: Up to 24 months ]
  • Adherence to program (Feasibility) [ Time Frame: At the end of the CAREFit-BMT program (Day 85) ]
  • Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score [ Time Frame: At the end of the CAREFit-BMT program (Day 85) ]
  • Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score [ Time Frame: At the end of the CAREFit-BMT program (Day 85) ]
  • Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score [ Time Frame: At the end of the CAREFit-BMT program (Day 85) ]

Central Contacts and Locations

Central contacts

Alexi Vasbinder, PhD, RN

206-221-4390avasbind@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Alexi Vasbinder, PhD, RN

206-221-4390avasbind@uw.edu

Principal Investigator:

Alexi Vasbinder, PhD, RN

More Information

Sponsor

University of Washington

Last update posted

Sep 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of Washington on 2026-09-11.