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

NCT ID: NCT05945121

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cardio-oncology program

The cardio-oncology program consists of a multimodal approach, which includes individualized exercise prescription following a detailed CV assessment and medical management of CV risk factors occurring over 8 weeks.

Group Type EXPERIMENTAL

Cardio-oncology program

Intervention Type 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)

Interventions

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Cardio-oncology program

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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salim Hayek

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer AnswerLine

Role: CONTACT

1-800-865-1125

Facility Contacts

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Cancer AnswerLine

Role: primary

800-865-1125

Other Identifiers

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HUM00223835

Identifier Type: OTHER

Identifier Source: secondary_id

U24HL157560

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2023.004

Identifier Type: -

Identifier Source: org_study_id

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