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RECRUITING
NCT07008911
NA

CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-09-30

Completion Date

2029-08-01

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

CardioHeartConnect

Participants in the CardioHeartConnect group engage in an eight-week digital cardiac rehabilitation program using the commercially available Peloton app. The intervention includes two daily modules (10-25 minutes total) on weekdays, focused on walking, strength, low-intensity cardio, yoga, pilates, and stretching. Modules progress in intensity over time. The program is delivered through the Ortus-iHealth platform, which prompts daily participation and integrates survey responses and smartwatch data. The intervention is designed to support physical activity, functional capacity, quality of life, and cardiovascular health among patients recovering from Transcatheter Aortic Valve Replacement (TAVR).

BEHAVIORAL

CardioHeartEd

CardioHeartEd is the control condition in which participants receive weekly cardiac rehabilitation-related educational resources through the Ortus-iHealth platform for eight weeks. The content is created by the American College of Cardiology and is designed to promote cardiovascular health following TAVR. Participants also receive a smartwatch to wear for self-monitoring, but do not receive structured exercise content. The CHE group controls for access to technology and general education about heart health.

Locations (1)

UCHealth Structural Heart and Valve Clinic

Aurora, Colorado, United States