The VESPA Pilot Study

Exercise Clinical Trial

— VESPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756245
• Other study ID #: 00023881
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University
• Contact: Kyle Kershner, BS
• Phone: 336-758-3728
• Email: kerski19[@]wfu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Exercise
• Loneliness
• Social Isolation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Wells Fargo Faculty Scholar Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability	Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire	Baseline
Secondary	Physical Activity	Average daily steps over one week as recorded via Garmin VivoSmart 4	Baseline, Week 4
Secondary	Social Relatedness	Score on the social relatedness subscale of the Brief Psychological Needs Satisfaction and Frustration Scale	Baseline, Week 4