A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
9. september 2026 opdateret af: University of Washington
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Alexi Vasbinder, PhD, RN
- Telefonnummer: 206-221-4390
- E-mail: avasbind@uw.edu
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Fred Hutch/University of Washington Cancer Consortium
-
Kontakt:
- Alexi Vasbinder, PhD, RN
- Telefonnummer: 206-221-4390
- E-mail: avasbind@uw.edu
-
Ledende efterforsker:
- Alexi Vasbinder, PhD, RN
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Supportive Care (CAREFit-BMT exercise program)
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.
|
Gennemgå indsamling af blod
Andre navne:
Hjælpestudier
Hjælpestudier
Hjælpestudier
Undergo moderate-intensity aerobic exercises
Andre navne:
Undergo strength training
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rates (Feasibility)
Tidsramme: 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.
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Up to 24 months
|
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Retention rates (Feasibility)
Tidsramme: 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.
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Up to 24 months
|
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Adherence to program (Feasibility)
Tidsramme: At the end of the CAREFit-BMT program (Day 85)
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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.
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At the end of the CAREFit-BMT program (Day 85)
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Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score
Tidsramme: 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.
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At the end of the CAREFit-BMT program (Day 85)
|
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Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score
Tidsramme: 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.
|
At the end of the CAREFit-BMT program (Day 85)
|
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Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score
Tidsramme: 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.
|
At the end of the CAREFit-BMT program (Day 85)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
Tidsramme: 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.
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At the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold
Tidsramme: 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. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak)
Tidsramme: 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. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted
Tidsramme: 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. |
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
Tidsramme: 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. |
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
Tidsramme: 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. |
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
|
Changes in cardiovascular (CV) symptoms
Tidsramme: 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.
|
Baseline up to the end of the CAREFit-BMT program (Day 85)
|
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Changes in CV biomarkers
Tidsramme: 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.
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Baseline up to the end of the CAREFit-BMT program (Day 85)
|
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Changes in quality of life
Tidsramme: 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.
|
Baseline up to the end of the CAREFit-BMT program (Day 85)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alexi Vasbinder, PhD, RN, Fred Hutch/University of Washington Cancer Consortium
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. oktober 2026
Primær færdiggørelse (Anslået)
3. april 2028
Studieafslutning (Anslået)
3. april 2028
Datoer for studieregistrering
Først indsendt
15. maj 2026
Først indsendt, der opfyldte QC-kriterier
26. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Leukæmi, myeloid
- Leukæmi
- Hemiske og lymfatiske sygdomme
- Leukæmi, Myeloid, Akut
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Terapeutik
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Fysioterapimodaliteter
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Interviews som emne
- Håndtering af eksemplar
- Modstandstræning
Andre undersøgelses-id-numre
- RG1125934
- KL2TR002317 (U.S. NIH-bevilling/kontrakt)
- NCI-2026-03252 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- FHIRB0021306 (Anden identifikator: Fred Hutch/University of Washington Cancer Consortium)
Plan for individuelle deltagerdata (IPD)
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