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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Appropriate for cardiac rehabilitation (CR) referral, as determined by the UCHealth Structural Heart \& Valve Clinic team

• Community-dwelling

• Reside in the United States

• Able to speak and understand English

• Able to provide informed consent

• Able to stand with or without an assistive device

• Able to see and hear content on the Peloton App via phone, tablet, or computer

Locations
United States
Colorado
UCHealth Structural Heart and Valve Clinic
RECRUITING
Aurora
Contact Information
Primary
Joshua Rosen
joshua.rosen@cuanschutz.edu
303-724-1889
Backup
Madeline Balser, MPH, MSW
madeline.balser@cuanschutz.edu
303-724-1883
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 200
Treatments
Experimental: CardioHeartConnect (CHC, Peloton Modules)
Participants will receive access to an eight-week series of pre-set, clinically reviewed Peloton exercise modules delivered via the Ortus-iHealth platform. They will also receive a smartwatch designed to monitor physical activity and support engagement in cardiac rehabilitation after Transcatheter Aortic Valve Replacement (TAVR).
Active_comparator: CardioHeartEd (CHE, Informational Materials)
Participants will receive access to an eight-week series of cardiac rehabilitation-related educational materials developed by the American College of Cardiology, delivered through the Ortus-iHealth platform. Participants in this arm will also receive a smartwatch to parallel the intervention group and support activity tracking.
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov