CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation

NCT07008911 | Recruiting DMC

• 2 other identifiers: 24-0628R61HL169336
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Keywords

Cardiac Rehabilitation; Transcatheter Aortic Valve Replacement; TAVR; Mobile Health; Peloton

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Change in functional capacity (self report)

  Baseline, 8 weeks, and 12 months

• Changes in functional capacity (smart watch)

  Baseline, 8 weeks, 12 months

• Change in cardiovascular-related quality of life

  Baseline, 8 weeks, and 12 months

• Changes in cardiovascular health status

  Baseline, 8 weeks, and 12 months

• Healthcare utilization

  8 weeks, 12 months

Other Outcomes (3)

• Safety tracking

  8 weeks and 12 months

• Participation in physical activity programing & cardiac rehab

  8 weeks and 12 months

• Intervention acceptability

  8 weeks

Study Arms (2)

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).

Behavioral: CardioHeartConnect

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.

Behavioral: CardioHeartEd

Interventions

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).

Also known as: CHC

CardioHeartConnect (CHC, Peloton Modules)

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.

Also known as: CHE

CardioHeartEd (CHE, Informational Materials)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UCHealth Structural Heart and Valve Clinic

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jennifer Portz, PhD, MSW

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Christopher Knoepke, PhD, MSW

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Rosen

CONTACT

303-724-1889; joshua.rosen@cuanschutz.edu

Madeline Balser, MPH, MSW

CONTACT

303-724-1883; madeline.balser@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the exercise modules (intervention) group or the education only (control) group

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 6, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)