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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. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Alexi Vasbinder, PhD, RN
  • Telefonnummer: 206-221-4390
  • E-Mail: avasbind@uw.edu

Studienorte

  • Vereinigte Staaten
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98109
        • Rekrutierung
        • Fred Hutch/University of Washington Cancer Consortium
        • Kontakt:
          • Alexi Vasbinder, PhD, RN
          • Telefonnummer: 206-221-4390
          • E-Mail: avasbind@uw.edu
        • Hauptermittler:
          • Alexi Vasbinder, PhD, RN

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: Sammlung von Bioproben
Blutabnahme durchführen
Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Sonstiges: Umfrageverwaltung
Nebenstudien
Sonstiges: Interview
Nebenstudien
Sonstiges: Überprüfung der elektronischen Patientenakte
Nebenstudien
Sonstiges: Aerobic Exercise
Undergo moderate-intensity aerobic exercises
Andere Namen:
  • Aerobe Aktivität
Sonstiges: Resistance Training
Undergo strength training
Andere Namen:
  • Krafttraining

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment rates (Feasibility)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Barriers and facilitators of Cardiorespiratory Fitness in Bone Marrow Transplant Program (CAREFit-BMT)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Washington

Mitarbeiter

National Center for Advancing Translational Sciences (NCATS)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Oktober 2026

Primärer Abschluss (Geschätzt)

3. April 2028

Studienabschluss (Geschätzt)

3. April 2028

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RG1125934
  • KL2TR002317 (US NIH Stipendium/Vertrag)
  • NCI-2026-03252 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021306 (Andere Kennung: Fred Hutch/University of Washington Cancer Consortium)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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