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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

9 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Alexi Vasbinder, PhD, RN
  • Número de telefone: 206-221-4390
  • E-mail: avasbind@uw.edu

Locais de estudo

  • Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Recrutamento
        • Fred Hutch/University of Washington Cancer Consortium
        • Contato:
          • Alexi Vasbinder, PhD, RN
          • Número de telefone: 206-221-4390
          • E-mail: avasbind@uw.edu
        • Investigador principal:
          • Alexi Vasbinder, PhD, RN

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Procedimento: Coleta de bioespécimes
Submeta-se a coleta de sangue
Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Outro: Administração de pesquisas
Estudos auxiliares
Outro: Entrevista
Estudos auxiliares
Outro: Revisão do Registro Eletrônico de Saúde
Estudos auxiliares
Outro: Aerobic Exercise
Undergo moderate-intensity aerobic exercises
Outros nomes:
  • Atividade Aeróbica
Outro: Resistance Training
Undergo strength training
Outros nomes:
  • Treinamento de força

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Recruitment rates (Feasibility)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Washington

Colaboradores

National Center for Advancing Translational Sciences (NCATS)

Investigadores

  • Investigador principal: Alexi Vasbinder, PhD, RN, Fred Hutch/University of Washington Cancer Consortium

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de outubro de 2026

Conclusão Primária (Estimado)

3 de abril de 2028

Conclusão do estudo (Estimado)

3 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

15 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de maio de 2026

Primeira postagem (Real)

1 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de setembro de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RG1125934
  • KL2TR002317 (Concessão/Contrato do NIH dos EUA)
  • NCI-2026-03252 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021306 (Outro identificador: Fred Hutch/University of Washington Cancer Consortium)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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