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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03252 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| KL2TR002317 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Other | Undergo moderate-intensity aerobic exercises |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | At the end of the CAREFit-BMT program (Day 85) |
| Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the CAREFit-BMT program (Day 85) |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexi Vasbinder, PhD, RN | Contact | 206-221-4390 | avasbind@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexi Vasbinder, PhD, RN | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Resistance Training | Other | Undergo strength training |
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| Biospecimen Collection | Procedure | Undergo collection of blood |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline up to the end of the CAREFit-BMT program (Day 85) |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D055070 | Resistance Training |
| D013048 | Specimen Handling |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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