NCT07745894

Brief Summary

The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Aug 2028

First Submitted

Initial submission to the registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in LE8 composite score

    Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health. Interpretation of the composite score usually follows these general categories: 0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health

    Baseline, 3 Months, 6 Months

Secondary Outcomes (3)

  • Number of CV-related hospital readmissions

    3 Months, 6 Months

  • Number of Deaths

    3 Months, 6 Months

  • Number of CV Deaths

    3 Months, 6 Months

Study Arms (2)

Virtual World-based Cardiac Rehabilitation

EXPERIMENTAL
Other: Virtual Cardiac Rehabilitation

Control Arm

ACTIVE COMPARATOR
Other: In-Person Cardiac Rehabilitation

Interventions

* Weekly Virtual Cardiac Rehabilitation Session * Virtual Nurse Coaching Visit (frequency: weekly) * Virtual Exercise Physiologist Visit (frequency: weekly) * Self-Directed Exercise: 3 sessions per week

Virtual World-based Cardiac Rehabilitation

Participants will attend three in-person cardiac rehabilitation sessions per week, each including: * Supervised exercise under the guidance of an Exercise Physiologist * Educational components related to cardiac health and lifestyle

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines:
  • Myocardial infarction within the preceding 12 months
  • 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
  • Aged ≥18 years
  • Basic Internet navigation skills
  • Active email address

You may not qualify if:

  • High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification103 given safety concern of unsupervised exercise:
  • Sudden cardiac arrest survivor
  • 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)
  • Pregnant (due to associated hormonal and weight changes)
  • Non-English-speaking
  • Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California

Irvine, California, 92697, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • LaPrincess Brewer, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lainey Moen

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations