RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-25
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05945121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult 18 years or older
  2. * Referred for HSCT evaluation
  3. * Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes)
  4. * Able to ambulate unassisted
  5. * Ability to understand and the willingness to sign a written informed consent
  6. * Ability to use Polar Flow heart rate application
  1. * Severe anemia (hemoglobin \<7 gm/dl)
  2. * Untreated high-risk coronary artery disease (left main, triple vessel disease)
  3. * Severe aortic stenosis
  4. * Recent fracture as assessed via self-report
  5. * Gross balance deficits
  6. * Severe pain with basic movement
  7. * Unable to ambulate unassisted or exercise
  8. * NYHA class IV heart failure
  9. * Adults unable to give consent, pregnant women, and prisoners are excluded from this study.

Contacts and Locations

Study Contact

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

Principal Investigator

Salim Hayek
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

  • Salim Hayek, PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-25
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-08-25
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular disease

Additional Relevant MeSH Terms

  • Hematopoietic Stem Cell Transplant