The VESPA Pilot Study (VESPA)

The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Loneliness; Behavior; Social Isolation
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Video Conference

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyle Kershner, BS; Phone Number: 336-758-3728; Email: kerski19@wfu.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Recruiting
      • Wake Forest University
      • Contact: Kyle Kershner, BS; Phone Number: 336-758-3728; Email: kerski19@wfu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Participants engage in intervention procedures using virtual reality software.	Behavioral: 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.
Active Comparator: Video Conference; Participants engage in intervention procedures using video conference software.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Average daily steps over one week as recorded via Garmin VivoSmart 4	Baseline, Week 4
Social Relatedness	Score on the social relatedness subscale of the Brief Psychological Needs Satisfaction and Frustration Scale	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Wells Fargo Faculty Scholar Endowment
• Investigators: Principal Investigator: Jason Fanning, PhD, Wake Forest University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Telehealth; Virtual Reality
• Other Study ID Numbers: 00023881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No