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

NCT ID: NCT07095504

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Cardiovascular Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Subject enrolled in a cardiac rehab program

Group Type EXPERIMENTAL

Virtual World-based Cardiac Rehabilitation (VWCR) program

Intervention Type BEHAVIORAL

36 Virtual World-based Cardiac Rehabilitation sessions over the course of 12 weeks (3 sessions/week)

Interventions

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Virtual World-based Cardiac Rehabilitation (VWCR) program

36 Virtual World-based Cardiac Rehabilitation sessions over the course of 12 weeks (3 sessions/week)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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LaPrincess C. Brewer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LaPrincess Brewer, M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of California (UCI), Irvine

Irvine, California, United States

Site Status NOT_YET_RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lainey Moen, M.A.

Role: CONTACT

507-266-7062

Facility Contacts

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Shaista Malik, M.D.

Role: primary

Jena Hayes

Role: primary

LaPrincess Brewer, M.D., M.P.H.

Role: primary

Other Identifiers

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25-002186

Identifier Type: -

Identifier Source: org_study_id

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