Clinical trial NCT07008911: CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
Official title: CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Disease
Keywords: Cardiac Rehabilitation
Transcatheter Aortic Valve Replacement
TAVR
Mobile Health
Peloton
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the exercise modules (intervention) group or the education only (control) group
Primary purpose: TREATMENT

Brief 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.

Detailed description: Despite strong evidence supporting cardiac rehabilitation (CR), participation following transcatheter aortic valve replacement (TAVR) remains low, particularly among patients with comorbidities, from underserved populations, or in rural areas. This randomized controlled trial tests the effectiveness and implementation of CardioHeartConnect (CHC), an eight-week, home-based cardiac rehabilitation intervention delivered through the commercially available Peloton app and supported by the Ortus-iHealth platform.

Two hundred patients recovering from TAVR at the UCHealth Structural Heart and Valve Clinic will be randomized 1:1 to either CardioHeartConnect or an attention control group, CardioHeartEd (CHE), which receives American College of Cardiology educational materials. All participants receive a smartwatch and access to the Ortus platform for data capture. CHC participants complete daily Peloton modules focusing on low-impact exercises including walking, stretching, yoga, and strength, tailored to CR guidelines and monitored by the research team.

The primary outcome is change in physical activity, measured by average daily steps at 8 weeks. Secondary outcomes include functional capacity (Duke Activity Status Index, VO2 max), cardiovascular health status (Life's Essential 8), health-related quality of life (Kansas City Cardiomyopathy Questionnaire), and self-efficacy. Safety events, participation in traditional CR, and implementation outcomes guided by the RE-AIM framework will also be assessed. Participants are followed for 12 months post-randomization.

This trial aims to inform scalable, equitable strategies for delivering CR through commercially available mobile health tools, particularly for patients who are underserved or waitlisted for traditional programs.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team

Primary outcomes:
measure: Change in physical activity measured by average daily steps
timeFrame: Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary)
Secondary outcomes:
measure: Change in functional capacity (self report)
timeFrame: Baseline, 8 weeks, and 12 months
measure: Changes in functional capacity (smart watch)
timeFrame: Baseline, 8 weeks, 12 months
measure: Change in cardiovascular-related quality of life
timeFrame: Baseline, 8 weeks, and 12 months
measure: Changes in cardiovascular health status
timeFrame: Baseline, 8 weeks, and 12 months
measure: Healthcare utilization
timeFrame: 8 weeks, 12 months
measure: Changes in self-efficacy
timeFrame: Baselin, 8 weeks, 12 months
Other outcomes:
measure: Safety tracking
timeFrame: 8 weeks and 12 months
measure: Participation in physical activity programing & cardiac rehab
timeFrame: 8 weeks and 12 months
measure: Intervention acceptability
timeFrame: 8 weeks
Locations:
city: Aurora
country: United States
facility: UCHealth Structural Heart and Valve Clinic
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Portz, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Christopher Knoepke, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
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