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NCT Number: NCT07616921

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Alexi Vasbinder, PhD, RN

CONTACT

[email protected]

206-221-4390

Alexi Vasbinder, PhD, RN

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

Undergo moderate-intensity aerobic exercises

Other names: Aerobic Activity

Resistance training

Other

Undergo strength training

Other names: Strength Training

Biospecimen Collection

Procedure

Undergo collection of blood

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Electronic Health Record Review

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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)

    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.

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

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

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. Changes in cardiovascular (CV) symptoms

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

    Will be measured using the Kansas City Cardiomyopathy Questionnaire-12. Standardized scores range from 0-100, with higher scores indicating better outcome.

  8. Changes in CV biomarkers

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

    Will include cardiac troponins (I & T), NT-pro-BNP, and IL-6 measured in collected blood samples through University of Washington Research Testing Service.

  9. Changes in quality of life

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexi Vasbinder, PhD, RN

CONTACT

[email protected]

206-221-4390

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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