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

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Health

• Registration Number: NCT07095504
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• High risk patients according to the AACVPR risk stratification 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
  • 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

• Pregnancy (due to associated hormonal and weight changes) per patient report

• Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

• Non-English-speaking patients due to logistical challenges with real time translation over a virtual platform

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Cardiovascular health score	Baseline, 3 Months, 6 Months	Cardiovascular health score will be determined by the American Heart Association's (AHA) Life's Simple 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.
Percent of Virtual world-based cardiac rehabilitation attended	Baseline, 6 Months	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).

Secondary Outcome Measures

Name	Time	Method
Number of cardiovascular hospital readmissions	Baseline, 6 Months	Cardiovascular Hospital readmissions will be determined by the number of times a patient is admitted to the hospital after initial admission.
All-cause mortality	6 Months	All-cause mortality will be determined by the number of patient deaths no matter the cause.

Trial Locations

Locations (2)

University of California (UCI), Irvine; 🇺🇸 Irvine, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States