Trials Today

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

Purpose

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.

Condition

Hematopoietic Stem Cell Transplant

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	Other: 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)

Recruiting Locations

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109

Contact:
Cancer AnswerLine
800-865-1125
CancerAnswerLine@med.umich.edu

More Details

NCT ID: NCT05945121
Status: Recruiting
Sponsor: University of Michigan Rogel Cancer Center

Study Contact

Cancer AnswerLine
1-800-865-1125
CancerAnswerLine@med.umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.