The VESPA Pilot Study

NCT ID: NCT04756245

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise Behavior Loneliness Social Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two 4-week interventions: a virtual-reality or video conference-based group-mediated activity program
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Virtual Reality

Participants engage in intervention procedures using virtual reality software.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within virtual reality software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both virtual reality and real-world physical activities.

Video Conference

Participants engage in intervention procedures using video conference software.

Group Type ACTIVE_COMPARATOR

Video Conference

Intervention Type BEHAVIORAL

Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within video conference software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both streaming video and real-world physical activities.

Interventions

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Virtual Reality

Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within virtual reality software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both virtual reality and real-world physical activities.

Intervention Type BEHAVIORAL

Video Conference

Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within video conference software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both streaming video and real-world physical activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wells Fargo Faculty Scholar Endowment

UNKNOWN

Sponsor Role collaborator

Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Jason Fanning

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Fanning, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

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Wake Forest University

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyle Kershner, BS

Role: CONTACT

336-758-3728

Facility Contacts

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Kyle Kershner, BS

Role: primary

336-758-3728

References

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Kershner K, Morton D, Robison J, N'dah KW, Fanning J. Assessing the Feasibility and Acceptability of Virtual Reality for Remote Group-Mediated Physical Activity in Older Adults: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e53156. doi: 10.2196/53156.

Reference Type DERIVED
PMID: 39514256 (View on PubMed)

Other Identifiers

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00023881

Identifier Type: -

Identifier Source: org_study_id

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