A Study of Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes

NCT07095504 | Active Not Recruiting

• 1 other identifier: 25-002186
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

A single-group, multi-center, non-randomized clinical trial will be conducted to assess the feasibility of implementing an enhanced virtual world-based cardiac rehabilitation (VWCR) program within a muti-site clinical trial.

Conditions

Cardiovascular Health

Outcome Measures

Primary Outcomes (2)

• Change in Cardiovascular health score

  Cardiovascular health score will be determined by the American Heart Association's (AHA) Life's Essential 8 (LS8). The scale is 0-100 pts (low to high), with LE8 categories as low (0-49), moderate (50-79) and high (80-100). A higher score indicates higher cardiovascular health.

  Baseline, 2 Months, 5 Months

• Percent of Virtual world-based cardiac rehabilitation attended

  Virtual world-based cardiac rehabilitation attended will be determined by the number of sessions prescribed vs the number of sessions attended (reported as a percent).

  Baseline, 6 Months

Secondary Outcomes (2)

• Number of cardiovascular hospital readmissions

  Baseline, 6 Months

• All-cause mortality

  6 Months

Study Arms (1)

Virtual World-Based Cardiac Rehab

EXPERIMENTAL

Behavioral: Virtual World-based Cardiac Rehabilitation (VWCR) program

Interventions

Virtual World-based Cardiac Rehabilitation (VWCR) program BEHAVIORAL

24 Virtual World-based Cardiac Rehabilitation sessions over the course of 8 weeks (3 sessions/week). Weekly visits include 1:1 video visit with Exercise Physiologist, 1:1 video visit with Nurse Coach, and virtual group education session followed by social discussion.

Virtual World-Based Cardiac Rehab

Eligibility Criteria

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

You may qualify if:

• Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines (diagnosed within the preceding 12 months) to include one or more of the following:
• Myocardial infarction
• Coronary artery bypass surgery
• Current stable angina (chest pain)
• Heart valve repair or replacement
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
• Heart or heart-lung transplant
• Stable chronic heart failure
• Receiving care at one of the participating CR centers
• Age ≥18 years
• Basic Internet navigation skills
• Active email address
• Access to Internet at home or public access (church, library, etc) for 3 virtual visits per week

You may not qualify if:

• High risk patients according to the AACVPR risk stratification44 given safety concern of unsupervised exercise
• Patients receiving continuous inotropic support
• Recent receipt of a mechanical support device
• Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
• Decompensated heart failure
• Symptomatic valvular heart disease
• Uncontrolled angina
• Pregnancy (due to associated hormonal and weight changes) per patient report
• Receiving continuous inotropic support
• Presence of a mechanical circulatory support device
• Decompensated heart failure
• Symptomatic valvular heart disease
• Uncontrolled angina
• Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise
• Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

University of California (UCI), Irvine

Irvine, California, 92617, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• LaPrincess Brewer, M.P.H.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)