NCT07616921 · University of Washington
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
What this study is 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.
View original scientific description
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.
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
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.
Retention rates (Feasibility)
Time frame: Up to 24 months
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment, also with 95% confidence intervals.
Adherence to program (Feasibility)
Time frame: At the end of the CAREFit-BMT program (Day 85)
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.
Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score
Time frame: At the end of the CAREFit-BMT program (Day 85)
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.
Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score
Time frame: At the end of the CAREFit-BMT program (Day 85)
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.
Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score
Time frame: At the end of the CAREFit-BMT program (Day 85)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations