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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Other: Cardio-oncology program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05945121

HUM00223835 (Other Identifier)

U24HL157560 (U.S. NIH Grant/Contract)

UMCC 2023.004

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cardio-oncology program

Experimental group

Description:

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.

Treatment:

Other: Cardio-oncology program