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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Subject enrolled in a cardiac rehab program
  • Behavioral: Virtual World-based Cardiac Rehabilitation (VWCR) program
    36 Virtual World-based Cardiac Rehabilitation sessions over the course of 12 weeks (3 sessions/week)

Recruiting Locations

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
Contact:
Jena Hayes
hayes.jena@mayo.edu

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Contact:
LaPrincess Brewer, M.D., M.P.H.
Brewer.LaPrincess@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Lainey Moen, M.A.
507-266-7062
moen.lainey@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.