Aortic Valve Disease, Aortic Valve Stenosis
Conditions
Keywords
Cardiac Rehabilitation, Transcatheter Aortic Valve Replacement, TAVR, Mobile Health, Peloton
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.
Interventions
BEHAVIORALCardioHeartConnect
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).
BEHAVIORALCardioHeartEd
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.
Sponsors
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to either the exercise modules (intervention) group or the education only (control) group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity measured by average daily steps | Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary) | Change in mean daily steps from baseline to 8 weeks, measured using smartwatch accelerometer data collected through the Ortus platform. Steps will serve as the primary endpoint to evaluate the effect of CardioHeartConnect compared with control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional capacity (self report) | Baseline, 8 weeks, and 12 months | Change in self-reported functional capacity measured by the Duke Activity Status Index (DASI) to assess physical function and cardiovascular fitness. |
| Changes in functional capacity (smart watch) | Baseline, 8 weeks, 12 months | Estimated V02 max is generated with heart rate and motion data from smart watches. This is a measure of the maximum amount of oxygen your body can consume during exercise, useful for the very fit to those managing illness. A higher V02 max indicates a higher level of cardio fitness and endurance. |
| Change in cardiovascular-related quality of life | Baseline, 8 weeks, and 12 months | Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess symptom burden, well-being, and overall cardiovascular health. |
| Changes in cardiovascular health status | Baseline, 8 weeks, and 12 months | Life's Essential 8 domains including diet, physical activity, nicotine exposure, sleep, BMI, blood pressure, cholesterol, and blood glucose. |
| Healthcare utilization | 8 weeks, 12 months | Routine clinical visits, urgent care and emergency department visits, all cause hospitalizations |
| Changes in self-efficacy | Baselin, 8 weeks, 12 months | Self-Efficacy for Managing Chronic Disease 6-item to assess ability to manage cardiovascular health. |
Countries
United States
Contacts
CONTACTJoshua Rosen
CONTACTMadeline Balser, MPH, MSW
PRINCIPAL_INVESTIGATORJennifer Portz, PhD, MSW
University of Colorado, Denver
PRINCIPAL_INVESTIGATORChristopher Knoepke, PhD, MSW
University of Colorado, Denver
Outcome results
None listed