Virtual vs Center-Based Cardiac Rehab for Cardiovascular Disease

(VWCR Trial)

Overseen By Moen R Lainey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: High risk cardiac, Inotropic support, Mechanical support, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether a virtual cardiac rehab program matches the effectiveness of traditional in-person rehab for individuals with heart problems. It compares a home-based, online program using a virtual world platform (Virtual World-Based Cardiac Rehabilitation, VWCR) to the usual center-based rehab (Center-Based Cardiac Rehabilitation, CBCR). The trial assesses patient adherence to each type and their effectiveness. Individuals who have experienced a heart attack or similar heart issues in the past year and can use the internet may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative rehab methods that could align with various lifestyles.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual world-based cardiac rehabilitation is safe for cardiovascular disease patients?

Research shows that virtual world-based cardiac rehabilitation (VWCR) is generally well-received by patients. Previous studies have examined its practicality and effectiveness, finding no serious safety issues. This trial is in the "Not Applicable" phase, indicating it does not aim to collect new safety data. As a digital program, VWCR avoids the physical risks associated with in-person treatments. Participants perform rehabilitation exercises at home using a virtual platform, making it a low-risk option for most people. Overall, the treatment appears safe, with no major problems reported in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual World-Based Cardiac Rehabilitation (VWCR) because it offers a fresh, digital twist on traditional cardiac rehab. Unlike the standard in-person programs, VWCR is delivered through a virtual platform like Second Life, allowing patients to complete their rehab from home. This approach not only makes cardiac rehab more accessible, especially for those with mobility or transportation issues, but also leverages the engaging nature of virtual environments to potentially increase patient participation and outcomes. By bringing cardiac rehab into the digital age, VWCR could revolutionize how we support heart health recovery.

What evidence suggests that this trial's cardiac rehabilitation programs could be effective for cardiovascular disease?

This trial will compare Virtual World-Based Cardiac Rehabilitation (VWCR) with Center-Based Cardiac Rehabilitation (CBCR) for individuals with heart disease. Research has shown that cardiac rehabilitation in a virtual world, like the VWCR arm of this trial, can be as effective as attending a rehab center. Studies have found that virtual rehab improves heart and muscle function during exercise and enhances mental well-being. Participants in virtual rehab programs tend to adhere well. This method aims to make cardiac rehab more accessible by allowing participation from home. ^{1 2 4 6 7}

Who Is on the Research Team?

LaPrincess C Brewer, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need cardiac rehab based on specific health conditions like recent heart attacks, surgeries, or stable heart issues. They must be able to use the internet and have an email address. It's not for high-risk patients with severe heart problems, those needing constant support, non-English speakers, or pregnant women.

Inclusion Criteria

Basic Internet navigation skills

I have an active email address.

I qualify for cardiac rehab due to a recent heart issue or surgery.

Exclusion Criteria

Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

Pregnant (due to associated hormonal and weight changes)

High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week cardiac rehabilitation program, either virtually or in-person, including patient education, self-monitoring, social support, and weekly telehealth visits

12 weeks

36 sessions (weekly telehealth visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months post-randomization

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Center-Based Cardiac Rehabilitation (CBCR)
• Virtual World-Based Cardiac Rehabilitation (VWCR)

Trial Overview The study compares a new Virtual World-Based Cardiac Rehabilitation (VWCR) program called 'Destination Cardiac Rehab' with traditional center-based rehabilitation to see if it's just as effective and whether people stick with it.

How Is the Trial Designed?

Group I: Virtual World-Based Cardiac Rehab (VWCR) Experimental Treatment 1 Intervention

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

Group II: Center-Based Cardiac Rehab (CBCR) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Published Research Related to This Trial

Using the Active+me platform alongside standard cardiac rehabilitation (CR) led to a significant increase in patient activation measures (PAM), indicating improved patient confidence and knowledge in managing their health, particularly among high-risk patients.

Participants also experienced reductions in resting blood pressure and waist circumference, along with a notable increase in self-reported physical activity levels, suggesting that Active+me effectively supports lifestyle changes in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in patient activation following cardiac rehabilitation using the Active+me digital healthcare platform during the COVID-19 pandemic: a cohort evaluation. Frith, G., Carver, K., Curry, S., et al.[2021]

In a study of 187 cardiac rehabilitation patients, both hybrid and virtual rehabilitation methods showed similar improvements in the 6-minute walk test compared to traditional in-person rehabilitation, indicating that these alternative delivery methods are effective.

While hybrid and virtual rehabilitation improved blood pressure control and anxiety levels similarly to in-person sessions, virtual patients showed less improvement in depression symptoms, suggesting that while these methods are effective, they may require additional support for mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation. Ganeshan, S., Jackson, H., Grandis, DJ., et al.[2023]

The virtual world-based cardiac rehabilitation program, Destination Rehab, was found to be feasible and highly acceptable among adult cardiac patients, with 93% attending at least one session and 71% attending 75% or more of the sessions.

While the program showed promising trends in improving cardiovascular health behaviors and biometrics, these changes were not statistically significant, indicating further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Informed Virtual World-Based Cardiac Rehabilitation Program as an Extension of Center-Based Cardiac Rehabilitation: MIXED-METHODS ANALYSIS OF A MULTICENTER PILOT STUDY. Brewer, LC., Abraham, H., Kaihoi, B., et al.[2023]

Mobile technologies, including wearable activity monitors and virtual rehabilitation solutions, have the potential to enhance adherence to cardiac rehabilitation, which is crucial for improving quality of life and reducing hospitalizations.

The review of 113 studies showed mixed results regarding the efficacy of virtual cardiac rehabilitation compared to traditional methods, but highlighted the importance of user adherence and long-term engagement as key benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. Lee, KCS., Breznen, B., Ukhova, A., et al.[2023]

A digital health intervention (DHI) combined with remote cardiac rehabilitation (CR) significantly improved access to CR, with 90% of participants completing the program out of 258 who consented from 1,643 referrals.

Participants in the DHI showed notable improvements in their 6-minute walk test distance and reductions in low-density lipoprotein cholesterol, along with a decrease in smoking rates, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. Harzand, A., Alrohaibani, A., Idris, MY., et al.[2023]

Cardiac rehabilitation (CR) programs significantly reduce future cardiac events and mortality, but only about 10% of eligible patients participate due to geographical barriers.

The development of virtual CR programs, utilizing technologies like the Internet and smartphones, shows promise in improving patient access and has demonstrated positive effects on clinical outcomes in small randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Lear, SA.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05897710

NCT05897710 | Virtual World-Based Cardiac Rehabilitation This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention.

2. reporter.nih.gov reporter.nih.gov/search/fGCcdcc_lkuKIdrvCZXRIw/project-details/11102253

A Multicenter Randomized Clinical Trial - NIH RePORTER Virtual World-based Cardiac Rehabilitation to Promote Data-Powered Cardiovascular Health Among Cardiac Patients: A Multicenter Randomized Clinical Trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9334153/

Novel Virtual World-Based Cardiac Rehabilitation Program to ... This report describes Destination Rehab, a novel virtual world-based cardiac rehabilitation program, which aims to increase cardiac rehabilitation access to ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030883

Protocol for the Destination Cardiac Rehab Randomized ... This study aims to evaluate efficacy and adherence of the virtual world–based CR program compared with center‐based CR within a community‐informed, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748922001523

Effectiveness of virtual reality in cardiac rehabilitation Virtual reality may benefit individuals undergoing cardiac rehabilitation since it can improve exercise capacity and psychological outcomes.

6. mayo.edu mayo.edu/research/clinical-trials/cls-20585974

Clinical Trials The purpose of this study is to determine the feasibility of conducting a randomized clinical trial to assess whether an enhanced virtual world-based cardiac ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation The review examines critical factors that influence the success of digital CR, such as digital literacy, concerns about data security, adherence to digital ...