Acute Myeloid LeukemiaNCT07616921
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
A study testing Aerobic Exercise, Resistance Training and Biospecimen Collection in people with Acute Myeloid Leukemia, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Aerobic Exercise, Resistance Training and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 3 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Alexi Vasbinder, PhD, RN, 206-221-4390, avasbind@uw.edu
Alexi Vasbinder, PhD, RN
About this study
Official title: CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Aerobic Exercise, Resistance Training, Biospecimen Collection, Electronic Health Record Review, Survey Administration
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Also called Aerobic Activity
Undergo moderate-intensity aerobic exercises
Resistance TrainingOther
Also called Strength Training
Undergo strength training
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (CAREFit-BMT exercise program) | Experimental | 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. Receives: Other: Aerobic Exercise; Other: Resistance Training; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the CAREFit-BMT program (Day 85)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to the end of the CAREFit-BMT program (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion3 Apr 2028 (estimated)
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Alexi Vasbinder, PhD, RN, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616921
- Sponsor's protocol ID
- RG1125934
- Other IDs
- NCI-2026-03252, KL2TR002317, FHIRB0021306
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07616921
- Acronym / sponsor ID
- RG1125934
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 3 Apr 2028 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (CAREFit-BMT exercise program) | Experimental | Other: Aerobic Exercise, Other: Resistance Training, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Survey Administration, Other: InterviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Able to exercise at low to moderate intensity, as evaluated by study staff
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: Aerobic ActivityUndergo moderate-intensity aerobic exercises | Other | Supportive Care (CAREFit-BMT exercise program) |
| Resistance TrainingAlso: Strength TrainingUndergo strength training | Other | Supportive Care (CAREFit-BMT exercise program) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood | Procedure or surgery | Supportive Care (CAREFit-BMT exercise program) |
| Electronic Health Record ReviewAncillary studies | Other | Supportive Care (CAREFit-BMT exercise program) |
| Survey AdministrationAncillary studies | Other | Supportive Care (CAREFit-BMT exercise program) |
| InterviewAncillary studies | Other | Supportive Care (CAREFit-BMT exercise program) |
Primary outcome
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexi Vasbinder, PhD, RN principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Resistance Training and Biospecimen Collection in people with Acute Myeloid Leukemia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexi Vasbinder, PhD, RN (206-221-4390, avasbind@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (Feasibility) (time frame: Up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.