Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R61HL169336 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioHeartConnect (CHC, Peloton Modules) | Experimental | 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). |
|
| CardioHeartEd (CHE, Informational Materials) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity measured by average daily steps | 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. | Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional capacity (self report) | Change in self-reported functional capacity measured by the Duke Activity Status Index (DASI) to assess physical function and cardiovascular fitness. | Baseline, 8 weeks, and 12 months |
| Changes in functional capacity (smart watch) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety tracking | Injury from exercise and falls will be assessed using EHR including hospitalizations, emergency department visits, urgent care visits and mortality safety endpoints. | 8 weeks and 12 months |
| Participation in physical activity programing & cardiac rehab |
Inclusion Criteria:
Exclusion Criteria:
- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Rosen | Contact | 303-724-1889 | joshua.rosen@cuanschutz.edu | |
| Madeline Balser, MPH, MSW | Contact | 303-724-1883 | madeline.balser@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Portz, PhD, MSW | University of Colorado, Denver | Principal Investigator |
| Christopher Knoepke, PhD, MSW | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Structural Heart and Valve Clinic | Recruiting | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
Participants will be randomized to either the exercise modules (intervention) group or the education only (control) group
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
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. |
| Baseline, 8 weeks, 12 months |
| Change in cardiovascular-related quality of life | Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess symptom burden, well-being, and overall cardiovascular health. | Baseline, 8 weeks, and 12 months |
| Changes in cardiovascular health status | Life's Essential 8 domains including diet, physical activity, nicotine exposure, sleep, BMI, blood pressure, cholesterol, and blood glucose. | Baseline, 8 weeks, and 12 months |
| Healthcare utilization | Routine clinical visits, urgent care and emergency department visits, all cause hospitalizations | 8 weeks, 12 months |
| Changes in self-efficacy | Self-Efficacy for Managing Chronic Disease 6-item to assess ability to manage cardiovascular health. | Baselin, 8 weeks, 12 months |
Self-report of participation in PA programming (i.e. silver sneakers); frequency Enrollment and attendance to usual CR |
| 8 weeks and 12 months |
| Intervention acceptability | Adapted user-rated mobile application rating scale for assing the acceptability and usabiltiy of digital tools. | 8 weeks |