An interventional study of Aerobic Exercise and Resistance Training in Acute Myeloid Leukemia, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
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.
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's planned enrollment of 30 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
High-risk patients as defined by one, or more, of the following criteria:
CARE-BMT score ≥ 5
Exclusion Criteria:
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
Undergo moderate-intensity aerobic exercises
Also known as: Aerobic Activity
Undergo strength training
Also known as: Strength Training
Undergo collection of blood
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Ancillary studies
Ancillary studies
Ancillary studies
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the CAREFit-BMT program (Day 85)
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
Participant-specific barriers and facilitators to enrollment, participation, and adherence, will be assessed through semi-structured qualitative interviews informed by the Capability, Opportunity, Motivation, and Behavior (COM-B) framework.
Time frame: At the end of the CAREFit-BMT program (Day 85)
Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold
Will be measured by cardiopulmonary exercise testing to assess anaerobic threshold. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.
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)
Will be measured by cardiopulmonary exercise testing to assess peak oxygen consumption (VO₂peak). Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.
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
Will be measured by cardiopulmonary exercise testing to assess VO₂peak percent-predicted. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.
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
Will be measured by cardiopulmonary exercise testing to assess respiratory exchange ratio at peak. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.
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
Will be measured by cardiopulmonary exercise testing to assess minute ventilation/carbon dioxide production (VE/VCO₂) slope. Within-participant change will be summarized as mean paired differences with two-sided 95% confidence intervals, standard deviations, and standardized mean changes. If distributions are notably non-normal (e.g. biomarkers), non-parametric paired methods will be used.
Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)
Changes in cardiovascular (CV) symptoms
Will be measured using the Kansas City Cardiomyopathy Questionnaire-12. Standardized scores range from 0-100, with higher scores indicating better outcome.
Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)
Changes in CV biomarkers
Will include cardiac troponins (I \& T), NT-pro-BNP, and IL-6 measured in collected blood samples through University of Washington Research Testing Service.
Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)
Changes in quality of life
Will be assessed using the Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire. Total scores range from 0-148, with higher scores indicating better outcome.
Time frame: Baseline up to the end of the CAREFit-BMT program (Day 85)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington