Virtual Cardiac Rehabilitation for Cardiovascular Health

Recruiting at 2 trial locations

Overseen By Lainey Moen, M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Inotropic support

Disqualifiers: Pregnancy, Visual/hearing impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new virtual cardiac rehabilitation program designed to help individuals improve heart health from home. The researchers aim to determine if this online approach can be effectively implemented across multiple clinics. The program, called the Virtual World-based Cardiac Rehabilitation (VWCR) program, seeks participants who have experienced heart-related events such as a heart attack, bypass surgery, or stable angina (chest pain) within the past year and who can regularly use the internet. This program may suit individuals with stable heart conditions who prefer or require remote health support. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health solutions from the comfort of home.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this virtual world-based cardiac rehabilitation program is safe?

Previous studies have shown that virtual world-based cardiac rehabilitation (VWCR) is safe for patients. Research indicates that digital and remote cardiac rehabilitation programs are generally well-tolerated, with most people handling them well. Reports suggest few serious side effects. For example, one study reviewing the safety and long-term effects of remote cardiac rehab found no significant increase in death rates or serious health risks. Another review highlighted that home-based cardiac rehab is effective and safe for people with heart disease. These findings support the idea that VWCR is a safe option for improving heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual World-based Cardiac Rehabilitation (VWCR) program because it offers a novel approach to cardiac rehabilitation through virtual reality technology. Unlike traditional in-person rehab programs that require patients to travel to a facility, this program allows individuals to participate from the comfort of their own homes. This not only makes it more accessible for people with mobility issues or busy schedules but also has the potential to increase adherence to rehab protocols. Additionally, the immersive virtual environment could enhance patient engagement and motivation, making the rehab process more effective.

What evidence suggests that this virtual world-based cardiac rehabilitation program is effective for cardiovascular health?

Research has shown that virtual reality for heart rehab can improve exercise performance and reduce stress in patients. This trial will enroll participants in the Virtual World-based Cardiac Rehabilitation (VWCR) program, which uses virtual settings to enhance accessibility. One study showed that VWCR yielded positive results, with participants adhering to the program and experiencing benefits similar to traditional, in-person rehab. The aim is to enable more people to complete their rehab at home, which benefits those who find traveling to a rehab center challenging. Overall, early evidence suggests VWCR could serve as a viable alternative to traditional heart rehab methods. ^{1 4 6 7 8}

Who Is on the Research Team?

LaPrincess Brewer, M.P.H.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with cardiovascular health issues who are interested in participating in a cardiac rehabilitation program. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

Basic Internet navigation skills

Access to Internet at home or public access (church, library, etc) for 3 virtual visits per week

I have an active email address.

Exclusion Criteria

Pregnancy (due to associated hormonal and weight changes) per patient report

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

I am not fluent in English and may face challenges with translation during virtual meetings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an enhanced virtual world-based cardiac rehabilitation program

6 months

Virtual sessions as prescribed

Follow-up

Participants are monitored for cardiovascular health outcomes and hospital readmissions

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual World-based Cardiac Rehabilitation (VWCR) program

Trial Overview The study is testing a Virtual World-based Cardiac Rehabilitation (VWCR) program to see if it's feasible and effective across multiple clinical sites. It's a single-group, non-randomized trial which means everyone gets the same intervention without comparison to another group.

How Is the Trial Designed?

Group I: Subject enrolled in a cardiac rehab program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11630969/

Effectiveness of virtual reality in cardiac rehabilitation ... Virtual reality-based interventions can be effective in improving patients' exercise capacity and negative emotions.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666084922004284

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

3. 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.

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. jacc.org jacc.org/doi/abs/10.1016/j.jaccas.2022.05.027

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...

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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10039430/

Virtual healthcare solutions for cardiac rehabilitation Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate ...