CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

ConditionsAortic Valve Stenosis Aortic Valve Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: CardioHeartConnect (CHC, Peloton Modules)Experimental treatment 1 intervention

Group B: CardioHeartEd (CHE, Informational Materials)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 8 weeks (Primary); 8 weeks, and 12 months (Secondary)

Secondary outcomes

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.

Time frame

Baseline, 8 weeks, and 12 months

Changes in functional capacity (smart watch)

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.

Time frame

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.

Time frame

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.

Time frame

Baseline, 8 weeks, and 12 months

Other outcomes

Safety tracking

Injury from exercise and falls will be assessed using EHR including hospitalizations, emergency department visits, urgent care visits and mortality safety endpoints.

Time frame

8 weeks and 12 months

Participation in physical activity programing & cardiac rehab

Self-report of participation in PA programming (i.e. silver sneakers); frequency Enrollment and attendance to usual CR

Time frame

8 weeks and 12 months

Intervention acceptability

Adapted user-rated mobile application rating scale for assing the acceptability and usabiltiy of digital tools.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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