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

2026년 9월 9일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Alexi Vasbinder, PhD, RN
  • 전화번호: 206-221-4390
  • 이메일: avasbind@uw.edu

연구 장소

  • 미국
    • Washington
      • Seattle, Washington, 미국, 98109
        • 모병
        • Fred Hutch/University of Washington Cancer Consortium
        • 연락하다:
          • Alexi Vasbinder, PhD, RN
          • 전화번호: 206-221-4390
          • 이메일: avasbind@uw.edu
        • 수석 연구원:
          • Alexi Vasbinder, PhD, RN

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 생물 표본 수집
채혈하다
다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
다른: 설문조사 관리
보조 연구
다른: 회견
보조 연구
다른: 전자 건강 기록 검토
보조 연구
다른: Aerobic Exercise
Undergo moderate-intensity aerobic exercises
다른 이름들:
  • 유산소 활동
다른: Resistance Training
Undergo strength training
다른 이름들:
  • 체력 훈련

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment rates (Feasibility)
기간: 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.
Up to 24 months
Retention rates (Feasibility)
기간: 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.
Up to 24 months
Adherence to program (Feasibility)
기간: 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.
At the end of the CAREFit-BMT program (Day 85)
Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score
기간: 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.
At the end of the CAREFit-BMT program (Day 85)
Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score
기간: 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)
Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
기간: 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.
At the end of the CAREFit-BMT program (Day 85)
Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
Changes in CV biomarkers
기간: 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.
Baseline up to the end of the CAREFit-BMT program (Day 85)
Changes in quality of life
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Washington

협력자

National Center for Advancing Translational Sciences (NCATS)

수사관

  • 수석 연구원: Alexi Vasbinder, PhD, RN, Fred Hutch/University of Washington Cancer Consortium

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 15일

기본 완료 (추정된)

2028년 4월 3일

연구 완료 (추정된)

2028년 4월 3일

연구 등록 날짜

최초 제출

2026년 5월 15일

QC 기준을 충족하는 최초 제출

2026년 5월 26일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RG1125934
  • KL2TR002317 (미국 NIH 보조금/계약)
  • NCI-2026-03252 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021306 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다