Clinical trial NCT04756245: The VESPA Pilot Study
Official title: The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise
Behavior
Loneliness
Social Isolation
Keywords: Telehealth
Virtual Reality
Physical Activity
Lead sponsor: Wake Forest University
Sponsor class: OTHER
Collaborators: name: Wells Fargo Faculty Scholar Endowment
First posted: 2021-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two 4-week interventions: a virtual-reality or video conference-based group-mediated activity program
Primary purpose: PREVENTION

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

Primary outcomes:
measure: The percentage of individuals attending all one-on-one and group calls
timeFrame: Weeks 0 through 4
measure: Acceptability
timeFrame: Baseline
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, Week 4
measure: Social Relatedness
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Jason Fanning, PhD
role: PRINCIPAL_INVESTIGATOR
References: