RECRUITING

CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

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

This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter aortic valve replacement (TAVR). The study aims to improve physical activity, functional capacity, quality of life, and cardiovascular health using wearable devices and a digital engagement platform. A total of 200 patients will be recruited from the UCHealth Structural Heart and Valve Clinic and randomized to either CardioHeartConnect or CardioHeartEd. Participants will be assessed at baseline, 8 weeks, and 12 months using surveys, smartwatch data, and electronic health records.

Official Title

CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2025-09-30
Study Completion:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07008911

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. * Appropriate for cardiac rehabilitation (CR) referral, as determined by the UCHealth Structural Heart \& Valve Clinic team
  2. * Community-dwelling
  3. * Reside in the United States
  4. * Able to speak and understand English
  5. * Able to provide informed consent
  6. * Able to stand with or without an assistive device
  7. * Able to see and hear content on the Peloton App via phone, tablet, or computer
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Joshua Rosen
CONTACT
303-724-1889
joshua.rosen@cuanschutz.edu
Madeline Balser, MPH, MSW
CONTACT
303-724-1883
madeline.balser@cuanschutz.edu

Principal Investigator

Jennifer Portz, PhD, MSW
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Christopher Knoepke, PhD, MSW
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

UCHealth Structural Heart and Valve Clinic
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Jennifer Portz, PhD, MSW, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver
  • Christopher Knoepke, PhD, MSW, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

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 Date2025-09-30
Study Completion Date2029-08-01

Study Record Updates

Study Start Date2025-09-30
Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Rehabilitation
  • Transcatheter Aortic Valve Replacement
  • TAVR
  • Mobile Health
  • Peloton

Additional Relevant MeSH Terms

  • Aortic Valve Stenosis
  • Aortic Valve Disease