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Recruiting NCT04756245

NCT04756245 The VESPA Pilot Study

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Clinical Trial Summary
NCT ID NCT04756245
Status Recruiting
Phase
Sponsor Wake Forest University
Condition Exercise
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2020-12-17
Primary Completion 2026-08-30

Eligibility & Interventions

Sex All sexes
Min Age 45 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Virtual RealityVideo Conference

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2020-12-17 with a primary completion date of 2026-08-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change. A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are: Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults. Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.

Eligibility Criteria

Inclusion Criteria: * Age of 45-80 years * Body mass index between 30-45 kg/m2 * Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week) * Have access to home Wi-Fi * Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls * Have a clear "VR space" (7'x7' object-free space) * Have an "Activity buddy" (spouse, child, caregiver, etc.) * Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater * Consent from a physician for study participation * Proficient in the English language * Willingness to create or use existing personal Facebook account for virtual reality activities. Exclusion Criteria: * Current involvement in other physical activity research studies * Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness) * Dependence on a cane or walker * More than 1 fall in the past year * Contraindication to exercise * Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months * History of or diagnosis of photosensitive epilepsy * Score of "severe" on any question in the Virtual Reality Sickness Questionnaire; * Unwillingness to use a head-mounted virtual reality system * Current severe or untreated depression

Contact & Investigator

Central Contact

Kyle Kershner, BS

✉ kerski19@wfu.edu

📞 336-758-3728

Principal Investigator

Jason Fanning, PhD

PRINCIPAL INVESTIGATOR

Wake Forest University

Frequently Asked Questions

Who can join the NCT04756245 clinical trial?

This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Exercise. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04756245 currently recruiting?

Yes, NCT04756245 is actively recruiting participants. Contact the research team at kerski19@wfu.edu for enrollment information.

Where is the NCT04756245 trial being conducted?

This trial is being conducted at Winston-Salem, United States.

Who is sponsoring the NCT04756245 clinical trial?

NCT04756245 is sponsored by Wake Forest University. The principal investigator is Jason Fanning, PhD at Wake Forest University. The trial plans to enroll 30 participants.

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