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

Overview

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.

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 d
• 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 h

Primary outcome measures

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

Secondary outcome measures (6)

• Change in functional capacity (self report) [Time frame: Baseline, 8 weeks, and 12 months]
• Changes in functional capacity (smart watch) [Time frame: Baseline, 8 weeks, 12 months]
• Change in cardiovascular-related quality of life [Time frame: Baseline, 8 weeks, and 12 months]
• Changes in cardiovascular health status [Time frame: Baseline, 8 weeks, and 12 months]
• Healthcare utilization [Time frame: 8 weeks, 12 months]
• Changes in self-efficacy [Time frame: Baselin, 8 weeks, 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• UCHealth Structural Heart and Valve Clinic — Aurora

Identifiers

NCT: NCT07008911 · 24-0628 · R61HL169336

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗