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NCT Number: NCT07008911

CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Structural Heart and Valve Clinic

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Joshua Rosen

CONTACT

[email protected]

303-724-1889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: CHC

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.

Other names: CHE

Primary outcomes

  1. Change in physical activity measured by average daily steps

    Time frame: 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 outcomes

  1. Change in functional capacity (self report)

    Time frame: 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.

  2. Changes in functional capacity (smart watch)

    Time frame: 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.

  3. Change in cardiovascular-related quality of life

    Time frame: Baseline, 8 weeks, and 12 months

    Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess symptom burden, well-being, and overall cardiovascular health.

  4. Changes in cardiovascular health status

    Time frame: 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.

  5. Healthcare utilization

    Time frame: 8 weeks, 12 months

    Routine clinical visits, urgent care and emergency department visits, all cause hospitalizations

  6. Changes in self-efficacy

    Time frame: Baselin, 8 weeks, 12 months

    Self-Efficacy for Managing Chronic Disease 6-item to assess ability to manage cardiovascular health.

Other outcomes

  1. Safety tracking

    Time frame: 8 weeks and 12 months

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

  2. Participation in physical activity programing & cardiac rehab

    Time frame: 8 weeks and 12 months

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

  3. Intervention acceptability

    Time frame: 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Rosen

CONTACT

[email protected]

303-724-1889

Madeline Balser, MPH, MSW

CONTACT

[email protected]

303-724-1883

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 6, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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