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

Overview

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.

Detailed 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.

Interventions

• Other Aerobic Exercise
  Undergo moderate-intensity aerobic exercises
• Other Resistance Training
  Undergo strength training
• Procedure Biospecimen Collection
  Undergo collection of blood
• Other Electronic Health Record Review
  Ancillary studies
• Other Survey Administration
  Ancillary studies
• Other Interview
  Ancillary studies

Primary outcome measures

• 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)]

Secondary outcome measures (9)

• Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) [Time frame: At the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak) [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted [Time frame: 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 [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in Minute ventilation/carbon dioxide production (VE/VCO₂) slope [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiovascular (CV) symptoms [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in CV biomarkers [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in quality of life [Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07616921 · RG1125934 · NCI-2026-03252 · KL2TR002317

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗