Actively Recruiting
CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement
Led by University of Colorado, Denver · Updated on 2025-08-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying CardioHeartConnect, a mobile cardiac rehabilitation program using Peloton fitness modules, for patients recovering from transcatheter aortic valve replacement (TAVR). This trial compares the effectiveness of this eight-week digital rehabilitation with educational materials in improving physical activity, functional capacity, quality of life, and cardiovascular health. The study aims to find scalable and equitable strategies to increase cardiac rehabilitation participation, especially for underserved or rural patients. Participants will be randomly assigned to either the CardioHeartConnect group, which engages in daily Peloton exercise modules focusing on walking, strength, yoga, and stretching delivered via the Ortus-iHealth platform, or the CardioHeartEd group, which receives weekly educational materials from the American College of Cardiology. Both groups receive a smartwatch to monitor activity and support engagement. The intervention lasts eight weeks. Participants will be evaluated at the start, after 8 weeks, and at 12 months using surveys, smartwatch data, and electronic health records. Researchers will measure physical activity by daily steps, functional capacity, cardiovascular health, quality of life, self-efficacy, healthcare use, and safety events. The study includes ongoing monitoring and aims to assess long-term effects over one year.
CONDITIONS
Brief Title
CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Appropriate for cardiac rehabilitation 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
You will not qualify if you...
- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants engage in an eight-week home-based cardiac rehabilitation program using the Peloton app or receive weekly cardiac rehabilitation educational materials. They also wear a smartwatch to monitor physical activity and support engagement in cardiac rehabilitation after Transcatheter Aortic Valve Replacement (TAVR).
Daily participation prompted through the app, with ongoing monitoring via smartwatch and platform
Duration - 12 months
Participants are followed for 12 months after the treatment period to assess long-term outcomes such as physical activity, functional capacity, cardiovascular health status, quality of life, self-efficacy, and healthcare utilization.
Assessments at 8 weeks and 12 months post-randomization
Trial Site Locations
Total: 1 location
1
UCHealth Structural Heart and Valve Clinic
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Joshua Rosen
M
Madeline Balser, MPH, MSW
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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