CClinicalTrials.gg
CompletedNCT07095504Updated Jul 31, 2026

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

An interventional study of Virtual World-based Cardiac Rehabilitation (VWCR) program in Cardiovascular Health, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Health
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Virtual World-Based Cardiac Rehab

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

Interventions

  • BehavioralVirtual World-based Cardiac Rehabilitation (VWCR) program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 2 Months, 5 Months

  2. 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).

    Time frame: Baseline, 6 Months

Secondary outcomes

  1. Number of cardiovascular hospital readmissions

    Cardiovascular Hospital readmissions will be determined by the number of times a patient is admitted to the hospital after initial admission.

    Time frame: Baseline, 6 Months

  2. All-cause mortality

    All-cause mortality will be determined by the number of patient deaths no matter the cause.

    Time frame: 6 Months

07

Study locations

3 sites
  • University of California (UCI), Irvine
    Irvine, California 92617, United States
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07095504
Lead sponsor
Mayo Clinic
Responsible party
LaPrincess C. Brewer (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 31, 2025
Start date
Dec 8, 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Jul 31, 2026

Study contacts

LaPrincess Brewer, M.P.H.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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