The VESPA Pilot Study

Not Applicable

Recruiting

• Conditions: Loneliness; Social Isolation; Exercise; Behavior
• Interventions: Behavioral: Video Conference; Behavioral: Virtual Reality

• Registration Number: NCT04756245
• Lead Sponsor: Wake Forest University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Conference	Video Conference	Participants engage in intervention procedures using video conference software.
Virtual Reality	Virtual Reality	Participants engage in intervention procedures using virtual reality software.

Primary Outcome Measures

Name	Time	Method
The percentage of individuals attending all one-on-one and group calls	Weeks 0 through 4	Feasibility will be assessed based on percentage of individuals attending all one-on-one and group calls
Acceptability	Baseline	Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States