Recruiting

VR Physical Activity

Sponsor:

Wake Forest University

Code:

NCT04756245

Conditions

Exercise

Behavior

Loneliness

Social Isolation

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Virtual Reality

Video Conference

Study Details

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

Study ID

NCT04756245

Start date

Dec 17, 2020

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Virtual Reality

Participants engage in intervention procedures using virtual reality software.

active comparator: Video Conference

Participants engage in intervention procedures using video conference software.

Interventions

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.

Primary outcome measure

  • The percentage of individuals attending all one-on-one and group calls [ Time Frame: Weeks 0 through 4 ]
  • Acceptability [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27109

Contacts

More Information

Sponsor

Wake Forest University

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • Telehealth
  • Virtual Reality
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University on 2025-07-16.