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NCT Number: NCT05945121

Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in Hematopoietic stem cell transplant (HSCT) recipients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Cancer AnswerLine

CONTACT

[email protected]

800-865-1125

Salim Hayek

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult 18 years or older
  • Referred for HSCT evaluation
  • Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes)
  • Able to ambulate unassisted
  • Ability to understand and the willingness to sign a written informed consent
  • Ability to use Polar Flow heart rate application

Exclusion criteria

  • Severe anemia (hemoglobin <7 gm/dl)
  • Untreated high-risk coronary artery disease (left main, triple vessel disease)
  • Severe aortic stenosis
  • Recent fracture as assessed via self-report
  • Gross balance deficits
  • Severe pain with basic movement
  • Unable to ambulate unassisted or exercise
  • NYHA class IV heart failure
  • Adults unable to give consent, pregnant women, and prisoners are excluded from this study.

Treatment and study plan

Cardio-oncology program

Other

Consented patients will undergo an initial CV evaluation as part of standard of care then participate in an 8-week at-home, personalized exercise intervention followed by an additional CV assessment prior to HSCT (after 8-weeks)

Primary outcomes

  1. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).

    Time frame: 8 weeks post enrollment

    Percent of eligible participants who are screened and give informed consent

  2. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (retention Rates).

    Time frame: 8 weeks post enrollment

    percentage of enrolled participants who complete pre-post CV assessments

  3. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).

    Time frame: 8 weeks post enrollment

    the number of participants recruited per month

  4. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (time to implement study protocol).

    Time frame: 8 weeks post enrollment

    the average amount of time required for participants to complete initial and follow-up CV assessments

  5. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).

    Time frame: 8 weeks post enrollment

    The percentage of days of exercised out of 24 days recommended over the 8 weeks for both aerobic and resistance activities.

  6. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Time).

    Time frame: 8 weeks post enrollment

    The average duration (min) of aerobic and resistance workouts over the course of the intervention.

  7. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Missing data).

    Time frame: 8 weeks post enrollment

    the percentage of missing data from study questionnaires.

  8. Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (overall satisfaction).

    Time frame: 8 weeks post enrollment

    Assessed qualitatively with in-depth, semi-structured, one-to-one exit interviews with participants. A member of the research team experienced with telephone interviews, but not involved in intervention delivery, will contact all patients within 1 week after completion of the final follow-up assessment.The researcher will facilitate the interviews using a conversational-style approach whilst referring to a topic guide. Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the program. The researcher will additionally ask questions regarding reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients. The topic guide will be used flexibly to allow patients to raise additional issues which they consider important to the study. Interviews will be recorded with participants knowledge and then transcribed, coded, and assessed for relevant themes and recommendations using iterative thematic analysis

  9. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in anaerobic threshold).

    Time frame: 8 weeks post enrollment

    change in anaerobic threshold from pre to post intervention reported in L/min

  10. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (change in VO2peak).

    Time frame: 8 weeks post enrollment

    change in VO2peak from pre to post intervention reported in ml/kg/min

  11. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (comparison of V02 peak to predicted).

    Time frame: 8 weeks post enrollment

    Comparison of V02 peak assessed after intervention in comparison to the predicted values reported as the percent difference between the values

  12. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (RER).

    Time frame: 8 weeks post enrollment

    change in RER (a ratio between cardiac dioxide output (VCO2)/oxygen uptake (VO2)) from pre to post intervention reported as the percent difference between the values

  13. Preliminary effectiveness of an 8-week cardio-oncology prehabilitation on measures of CRF in high-risk HSCT candidates (VE/VC02 slope).

    Time frame: 8 weeks post enrollment

    Change in VE/VC02 slope (defined as the change in minute ventilation per unit of carbon dioxide production) from pre to post intervention

Secondary outcomes

  1. Symptom assessment scores after an 8-week cardio-oncology prehabilitation program.

    Time frame: 8 weeks post enrollment

    Frequency and severity of cardiovascular symptoms (fatigue, shortness of breath, edema) will be assessed using the short Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health. Items are grouped into the four domains; Physical limitation, Symptom frequency, Quality of life, and Social limitation.

  2. Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program

    Time frame: 8 weeks post enrollment

    Overall quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Responses are given on a single-item ranging in score from 0 to 100. A high scale score represents a higher response level.

  3. Difference in biomarkers after an 8-week cardio-oncology prehabilitation program

    Time frame: 8 weeks post enrollment

    High-sensitivity troponin-I (RayBiotech), B-type natriuretic peptide (BNP) (RayBiotech), and soluble urokinase plasminogen activator receptor (suPAR) (Virogates) will be measured in residual serum samples collected as part of usual care using enzyme-linked immunosorbent assays.

  4. Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program

    Time frame: 8 weeks post enrollment

    We will calculate the percentage of participants evaluated who end up being eligible for HSCT and compare rates to the number of participants who are referred to cardio-oncology, do not receive the intervention, and are considered ineligible.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer AnswerLine

CONTACT

[email protected]

1-800-865-1125

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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