Virtual World-Based Cardiac Rehabilitation

NCT05897710 | Completed DMC

• 1 other identifier: 22-011357
• Study Type: interventional
• Target: 2,881
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.

Conditions

Cardiac Event; Telemedicine; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (10)

• Life's Essential 8 component: Self-reported healthy diet

  Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Self-reported physical activity

  Changes from baseline in physical activity using the International Physical Activity Questionnaire (IPAQ), a 12-item questionnaire classifying physical activity as "low," "moderate," or "high" intensity physical activity (minutes/day) over the prior week

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Self-Reported smoking status

  Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past smoking habits

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Sleep Quality

  Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Body Mass Index (BMI)

  Changes from baseline in BMI as calculated with weight (kg) and height (m), reported as kg/m\^2

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Cholesterol

  Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Blood Glucose

  Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL)

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 component: Blood Pressure

  Changes from baseline in systolic and diastolic blood pressure measurements; average of three sitting readings in mmHg

  Baseline, 3 months, and 6 months post-randomization

• Life's Essential 8 composite score: Cardiovascular health

  Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).

  Baseline, 3 months, and 6 months post-randomization

• Number of sessions attended by participants

  Optimal adherence defined as completion of 70% or more of weekly visits (in-person or virtual). Attendance measured by CR staff for control group, and by VWCR web administrators, Exercise Physiologists, and Nurse Coaches in the VWCR arm.

  Baseline through 12-week program

Secondary Outcomes (10)

• MACE (Major Adverse Cardiovascular Events) 3 months post-randomization

  3 months and 6 months post-randomization

• Exercise Sessions

  Baseline through 12-week (36 session) cardiac rehabilitation program

• Functional Capacity

  Baseline, 3 months, and 6 months post-randomization

• Health-related quality of life

  Baseline, 3 months, and 6 months post-randomization

• Physical Activity Self-efficacy

  Baseline, 3 months, and 6 months post-randomization

Study Arms (2)

Center-Based Cardiac Rehab (CBCR)

ACTIVE COMPARATOR

Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program.

Other: Center-Based Cardiac Rehabilitation (CBCR)

Virtual World-Based Cardiac Rehab (VWCR)

EXPERIMENTAL

Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program.

Other: Virtual World-Based Cardiac Rehabilitation (VWCR)

Interventions

Virtual World-Based Cardiac Rehabilitation (VWCR) OTHER

12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment.

Also known as: Destination Cardiac Rehab

Virtual World-Based Cardiac Rehab (VWCR)

Center-Based Cardiac Rehabilitation (CBCR) OTHER

Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility

Center-Based Cardiac Rehab (CBCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 stratification (e.g., 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) given safety concern of unsupervised exercise20
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Johns Hopkins University: collaborator
• University of California, Irvine: collaborator
• University of Mississippi Medical Center: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Brewer LC, Abraham H, Clark D 3rd, Echols M, Hall M, Hodgman K, Kaihoi B, Kopecky S, Krogman A, Leth S, Malik S, Marsteller J, Mathews L, Scales R, Schulte P, Shultz A, Taylor B, Thomas R, Wong N, Olson T. Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial. J Am Heart Assoc. 2023 Dec 5;12(23):e030883. doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.

  PMID: 38014699 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• LaPrincess Brewer, M.D., M.P.H.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 9, 2023
• Study Start: March 7, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)