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NCT07616921

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

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
University of Washington
~30 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Aerobic ExerciseResistance TrainingBiospecimen CollectionElectronic Health Record ReviewSurvey AdministrationInterview

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment rates (Feasibility)
Measured over Up to 24 months
+5 more outcomes measured

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Alexi Vasbinder, PhD, RN · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Alexi Vasbinder, PhD, RN
[email protected]
206-221-4390
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recruitment rates (Feasibility)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)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)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 scoreAt 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 scoreAt 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 scoreAt 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.