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

NCT07616921 | Not Yet Recruiting

• 3 other identifiers: RG1125934NCI-2026-03252KL2TR002317
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Recruitment rates (Feasibility)

  Recruitment will be calculated as the proportion of eligible patients who provide informed consent, with 95% confidence intervals, and reasons for ineligibility or refusal summarized from screening logs.

  Up to 24 months

• Retention rates (Feasibility)

  Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals.

  Up to 24 months

• Adherence to program (Feasibility)

  Adherence will be evaluated from both aerobic and resistance training participation, including the percentage of prescribed sessions completed and average weekly minutes of moderate-intensity aerobic activity from wearable device data.

  At the end of the CAREFit-BMT program (Day 85)

• Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score

  Acceptability will be assessed using validated instrument, Acceptability of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater acceptability.

  At the end of the CAREFit-BMT program (Day 85)

• Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score

  Will be assessed using validated instrument, Intervention Appropriateness Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater appropriateness.

  At the end of the CAREFit-BMT program (Day 85)

• Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score

  Will be assessed using validated instrument, Feasibility of Intervention Measure, summarized as means with standard deviations. Scores range from 1 to 5, with higher scores indicating greater feasibility.

  At the end of the CAREFit-BMT program (Day 85)

Secondary Outcomes (9)

• Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)

  At the end of the CAREFit-BMT program (Day 85)

• Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold

  Baseline up to the end of the CAREFit-BMT program (Day 85)

• Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak)

  Baseline up to the end of the CAREFit-BMT program (Day 85)

• Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted

  Baseline up to the end of the CAREFit-BMT program (Day 85)

• Changes in cardiorespiratory fitness (CRF): Mean change in Respiratory exchange ratio at peak

  Baseline up to the end of the CAREFit-BMT program (Day 85)

Study Arms (1)

Supportive Care (CAREFit-BMT exercise program)

EXPERIMENTAL

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.

Other: Aerobic Exercise; Other: Resistance Training; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration; Other: Interview

Interventions

Aerobic Exercise OTHER

Undergo moderate-intensity aerobic exercises

Also known as: Aerobic Activity

Supportive Care (CAREFit-BMT exercise program)

Resistance Training OTHER

Undergo strength training

Also known as: Strength Training

Supportive Care (CAREFit-BMT exercise program)

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Supportive Care (CAREFit-BMT exercise program)

Electronic Health Record Review OTHER

Ancillary studies

Supportive Care (CAREFit-BMT exercise program)

Survey Administration OTHER

Ancillary studies

Supportive Care (CAREFit-BMT exercise program)

Interview OTHER

Ancillary studies

Supportive Care (CAREFit-BMT exercise program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Exercise; Resistance Training; Specimen Handling; Interviews as Topic

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexi Vasbinder, PhD, RN

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexi Vasbinder, PhD, RN

CONTACT

206-221-4390; avasbind@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)