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

Mayo Clinic

Status: Enrolling

Conditions: Cardiovascular Health

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07095504

25-002186

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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

• Currently participating in a cardiac rehab program

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Subject enrolled in a cardiac rehab program

Experimental group

Treatment:

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