The VESPA Pilot Study

NCT04756245 | Recruiting

• 1 other identifier: 00023881
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Behavior; Loneliness; Social Isolation

Keywords

Telehealth; Virtual Reality; Physical Activity

Outcome Measures

Primary Outcomes (2)

• The percentage of individuals attending all one-on-one and group calls

  Feasibility will be assessed based on percentage of individuals attending all one-on-one and group calls

  Weeks 0 through 4

• Acceptability

  Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire

  Baseline

Secondary Outcomes (2)

• Physical Activity

  Baseline, Week 4

• Social Relatedness

  Baseline, Week 4

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants engage in intervention procedures using virtual reality software.

Behavioral: Virtual Reality

Video Conference

ACTIVE COMPARATOR

Participants engage in intervention procedures using video conference software.

Behavioral: Video Conference

Interventions

Virtual Reality 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.

Virtual Reality

Video Conference 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.

Video Conference

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• Wells Fargo Faculty Scholar Endowment: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39514256 DERIVED

MeSH Terms

Conditions

Motor Activity; Behavior; Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior

Study Officials

• Jason Fanning, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Kershner, BS

CONTACT

336-758-3728; kerski19@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: December 17, 2020
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)