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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 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Alexi Vasbinder, PhD, RN
  • Numero di telefono: 206-221-4390
  • Email: avasbind@uw.edu

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98109
        • Reclutamento
        • Fred Hutch/University of Washington Cancer Consortium
        • Contatto:
          • Alexi Vasbinder, PhD, RN
          • Numero di telefono: 206-221-4390
          • Email: avasbind@uw.edu
        • Investigatore principale:
          • Alexi Vasbinder, PhD, RN

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: Raccolta di campioni biologici
Sottoponiti al prelievo di sangue
Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Altro: Amministrazione del sondaggio
Studi accessori
Altro: Colloquio
Studi accessori
Altro: Revisione del Fascicolo Sanitario Elettronico
Studi accessori
Altro: Aerobic Exercise
Undergo moderate-intensity aerobic exercises
Altri nomi:
  • Attività aerobica
Altro: Resistance Training
Undergo strength training
Altri nomi:
  • Allenamento della forza

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rates (Feasibility)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Center for Advancing Translational Sciences (NCATS)

Investigatori

  • Investigatore principale: Alexi Vasbinder, PhD, RN, Fred Hutch/University of Washington Cancer Consortium

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 ottobre 2026

Completamento primario (Stimato)

3 aprile 2028

Completamento dello studio (Stimato)

3 aprile 2028

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RG1125934
  • KL2TR002317 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2026-03252 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021306 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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