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

Официальное название

CAREFit-BMT Program to Improve Cardiac Reserve in High-Risk Acute Myeloid Leukemia Patients Preparing to Undergo Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Aerobic Exercise
  Undergo moderate-intensity aerobic exercises
• Другое Resistance Training
  Undergo strength training
• Процедура Biospecimen Collection
  Undergo collection of blood
• Другое Electronic Health Record Review
  Ancillary studies
• Другое Survey Administration
  Ancillary studies
• Другое Interview
  Ancillary studies

Первичные конечные точки

• Recruitment rates (Feasibility) [Срок оценки: Up to 24 months]
• Retention rates (Feasibility) [Срок оценки: Up to 24 months]
• Adherence to program (Feasibility) [Срок оценки: At the end of the CAREFit-BMT program (Day 85)]
• Overall satisfaction (Feasibility): Acceptability of Intervention Measure mean score [Срок оценки: At the end of the CAREFit-BMT program (Day 85)]
• Overall satisfaction (Feasibility): Intervention Appropriateness Measure mean score [Срок оценки: At the end of the CAREFit-BMT program (Day 85)]
• Overall satisfaction (Feasibility): Feasibility of Intervention Measure mean score [Срок оценки: At the end of the CAREFit-BMT program (Day 85)]

Вторичные конечные точки (9)

• Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT) [Срок оценки: At the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in Anaerobic threshold [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in Peak oxygen consumption (VO₂peak) [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiorespiratory fitness (CRF): Mean change in VO₂peak percent-predicted [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in cardiovascular (CV) symptoms [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in CV biomarkers [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]
• Changes in quality of life [Срок оценки: Baseline up to the end of the CAREFit-BMT program (Day 85)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT07616921 · RG1125934 · NCI-2026-03252 · KL2TR002317

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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