ExerciseVESPANCT04756245
The VESPA Pilot Study
A study testing Virtual Reality and Video Conference in people with Exercise and Behavior, run by Wake Forest University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Behavior, Loneliness
- What is being tested?
- Virtual Reality and Video Conference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Kyle Kershner, BS, 336-758-3728, kerski19@wfu.edu
About this study
Official title: 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:
Read more
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
- Being tested
- Virtual Reality, Video Conference
- Keywords
- Telehealth, Virtual Reality, Physical Activity
- Medical subject headings
- Motor Activity, Behavior, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
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 ConferenceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants engage in intervention procedures using virtual reality software. Receives: Behavioral: Virtual Reality |
| Video Conference | Active comparator | Participants engage in intervention procedures using video conference software. Receives: Behavioral: Video Conference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Weeks 0 through 4
Acceptability
Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire
Measured: Baseline
Secondary outcomes (2)
Physical Activity
Average daily steps over one week as recorded via Garmin VivoSmart 4
Measured: Baseline, Week 4
Social Relatedness
Score on the social relatedness subscale of the Brief Psychological Needs Satisfaction and Frustration Scale
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start17 Dec 2020
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two 4-week interventions: a virtual-reality or video conference-based group-mediated activity program
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Wells Fargo Faculty Scholar Endowment
- Responsible party
- Principal investigator, Jason Fanning, Wake Forest University
- Investigators
- Jason Fanning, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756245
- Sponsor's protocol ID
- 00023881
- Acronym
- VESPA
- Status last verified
- Jul 2025
- First submitted
- 12 Feb 2021
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kershner K, Morton D, Robison J, N'dah KW, Fanning J. Assessing the Feasibility and Acceptability of Virtual Reality for Remote Group-Mediated Physical Activity in Older Adults: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e53156. doi: 10.2196/53156.
PubMed 39514256
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study
- ClinicalTrials.gov ID
- NCT04756245
- Acronym / sponsor ID
- VESPA / 00023881
- Conditions
- Exercise, Behavior, Loneliness, Social Isolation
- Keywords
- Telehealth, Virtual Reality, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Wells Fargo Faculty Scholar Endowment
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two 4-week interventions: a virtual-reality or video conference-based group-mediated activity program
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual RealityParticipants engage in intervention procedures using virtual reality software. |
| Video Conference | Active comparator | Behavioral: Video ConferenceParticipants engage in intervention procedures using video conference software. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityParticipants 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. | Behavioural | Virtual Reality |
| Video ConferenceParticipants 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. | Behavioural | Video Conference |
Primary outcome
The percentage of individuals attending all one-on-one and group calls
Time frame: Weeks 0 through 4
Feasibility will be assessed based on percentage of individuals attending all one-on-one and group calls
Acceptability
Time frame: Baseline
Percentage of individuals reporting no severe symptoms in response to virtual reality on the virtual reality sickness questionnaire
2 secondary outcomes
Physical Activity
Time frame: Baseline, Week 4
Social Relatedness
Time frame: Baseline, Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 39514256Kershner K, Morton D, Robison J, N'dah KW, Fanning J. Assessing the Feasibility and Acceptability of Virtual Reality for Remote Group-Mediated Physical Activity in Older Adults: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Nov 8;8:e53156. doi: 10.2196/53156.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Fanning, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Video Conference in people with Exercise and Behavior, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle Kershner, BS (336-758-3728, kerski19@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of individuals attending all one-on-one and group calls (time frame: Weeks 0 through 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.