CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07008911
Status
Recruiting
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Conditions

  • Aortic Valve Disease
  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CardioHeartConnect — BEHAVIORAL
    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).
  • CardioHeartEd — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in physical activity measured by average daily steps [ Time Frame: Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCHealth Structural Heart and Valve ClinicAuroraColorado80045
Joshua Rosen
[email protected]
303-724-1889

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By research site
UCHealth Structural Heart and Valve Clinic· Aurora, CO

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