A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant

University of Washington

Status

Begins enrollment this month

Conditions

Acute Myeloid Leukemia

Treatments

Other: Interview

Other: Aerobic Exercise

Other: Survey Administration

Other: Resistance Training

Other: Electronic Health Record Review

Procedure: Biospecimen Collection

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07616921

KL2TR002317 (U.S. NIH Grant/Contract)

RG1125934

NCI-2026-03252 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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