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ControlIVRTENCT07213388

Immersive Virtual Reality vs Treadmill Exercise Project

A study testing VRPA and Treadmill in people with Control and Virtual Reality Physical Activity, run by Rowan University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research project is to examine the feasibility and acceptability of a virtual reality-based physical activity (VRPA) intervention for inactive adults compared to more traditional forms of physical activity. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
VRPA and Treadmill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
1 Sep 2024to 22 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Be inactive (i.e., do not meet physical activity guidelines)
  • have no current neurological, psychiatric, sensory, or motor impairment, and normal or corrected-to-normal vision (only thin wire glasses or contacts can be used)
  • have no history of motion sickness
  • have the ability to exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) (Warburton et al., 2019)
  • Have not fallen to the point of injury in the last 6 months.
  • Be willing to wear an activity tracker
  • 18-64 years,

Who cannot join

  • Do not meet the inclusion criteria
  • Struggle to use operate a VR headset
  • Cannot read
  • Have concerns about balance/falling while using a VR headset,
  • Unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rowan University

    Glassboro, New Jersey, 08028

Other trials in United States

About this study

Official title: Effects of Different Physical Activity Modalities on Physiological and Psychological Outcomes

The purpose of this research project is to examine the feasibility and acceptability of a virtual reality-based physical activity (VRPA) intervention for inactive adults compared to more traditional forms of physical activity. The project will explore the relationship between VRPA engagement and cognition, biological measures (calories burned, heart rate, and active minutes), rate of perceived exertion, flow, affect, and enjoyment in physical activity as well.

Read the detailed description

The feasibility and acceptability of a Virtual Reality Physical Activity (VRPA) intervention will be examined. VRPA will be compared with more traditional modes of physical activity (e.g., walking on a treadmill) with regard to physical biomarkers (i.e., heart rate, calories burned, active minutes), flow state (i.e., Flow Short Scale), cognition (e.g., Stroop Test, Trail Making Test, Digital version of the WRAML-2 Symbolic Working Memory Test-Part 1, and Digital Backward Digit Span), affect (e.g., Activation-Deactivation Adjective List and DASS-21), perceived exertion (e.g., Borg's Rate of Perceived Exertion and one question regarding how hard they think they will exert themselves), willingness (i.e., to pay, intent to engage in physical activity), and physical enjoyment (i.e., Physical Activity Enjoyment Scale).

  1. Recruit and enroll 60 participants
  2. Participants will be recruited through the SONA system (i.e., student pool for collecting psychological research), word-of-mouth, email lists, flyers, and online classified ads
  3. Participants will be screened to ensure they meet the inclusion criteria
  4. Participants will be randomly assigned to one of three conditions (VR, Treadmill + Music, Sitting + Music)
  5. Participants will complete baseline measures a. Demographic information will be collected (e.g., ethnicity, height, weight, experience with exergames, current physical activity, physical activity readiness) b. Participants will: i. Complete the following surveys
  6. Cognition 2. Affect 3. How hard do they think they will exert themselves 4. Willingness ii. Get the following measurements taken:
  7. Heart Rate (HR) 6. Participants will engage in a warm-up/acclimation period on either the VR exergame or treadmill condition 7. Participants will engage in exercise for 20-30 minutes in the VR/treadmill condition, or sit quietly listening to music (control condition)
  8. HR will be measured during all 3 conditions
  9. The treadmill condition will be configured to a level that allows participants to engage in comfortable conversation while experiencing some breathlessness (i.e., brisk/moderate pace) 8. Post-exercise/sitting, participants will
  10. Complete the following surveys: i. Feasibility ii. Acceptability iii. Cognition iv. Flow v. Affect vi. Borg's Rate of Perceived Exertion (RPE) vii. Willingness viii. Physical Enjoyment b. Get the following measurements taken: i. Heart Rate ii. Calories burned
Being tested
VRPA, Treadmill, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRPABehavioural

    Effects of virtual reality physical activity on outcomes

  • TreadmillBehavioural

    Effects of treadmill walking with music on outcomes

  • ControlBehavioural

    Effects of music while sitting on outcomes

Study groups in NCT07213388
Study groupRoleWhat they receive
ControlActive comparatorParticipants will sit quietly while listening to the same music playlist that is played during the VRPA condition.
Receives: Behavioral: Control
TreadmillExperimentalParticipants will walk on a treadmill while listening to the same playlist that is played during the VRPA condition.
Receives: Behavioral: Treadmill
Virtual Reality Physical Activity (VRPA)ExperimentalParticipants will wear the VR headset and complete one pre-selected exercise session.
Receives: Behavioral: VRPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pace of participant recruitment

    enrollment rate of 6 participants per month

    Measured: Up to 24 months

  2. Number of participants willing to continue using the assigned exercie modality

    Willingness to continue using the exercise modality to which the participants were assigned and self-report enjoyment from engaging in the assigned exercise.

    Measured: Day 1

  3. Percentage of participants who complete the required tasks in each condition

    Are participants able to complete the required tasks

    Measured: Day 1

Secondary outcomes (9)

  1. Changes in Heart Rate

    Differences in heart rate from pre- to post session

    Measured: Day 1

  2. Self-reported measures of "flow" associated with the assigned conditions

    Flow will be assessed using the Flow Short Scale (Rheinberg et al, 2003) that is comprised of 13 questions answered on a 7-point scale (1 = Not at all, 7 = very much). Scores can range from 13-91, with lower scores indicating less of a "flow state" or feelings of immersion in the assigned activity.

    Measured: Day 1

  3. Changes in affect

    Using the Activation-Deactivation Checklist (Thayer et al., 1986), participants will rate 20 different adjectives on a 4-point scale (1= definitely feel, 2= feel slightly, 3= cannot decide, 4= definitely do not feel) before they engage in the assigned activity and after they engage in the assigned activity. Lower numbers will indicate higher endorsements of a particular feeling, but the primary outcome will examine any changes in pre- to post-activity ratings of the different affective states.

    Measured: Day 1

  4. Rate of percieved exertion

    Borg's Rate of Perceived Exertion will be used to measure how participants rate their perceived exertion on a scale of 6 (no exertion at all) to 20 (maximal exertion) (Borg, 1982). The scale is anchored to the participant's subjective perception, with descriptors such as "extremely hard." Rate of perceived exertion will be evaluated post-activity only and will be compared across groups.

    Measured: Day 1

  5. Changes in Stroop Color and Word Test

    The Stroop Color and Word Test (Golden et al, 2002) will be conducted pre- and post-assigned activities. Raw scores (e.g., reaction times, errors) will be calculated and changes in those scores from pre- to post-activity will be determined.

    Measured: Day 1

  6. Number of Calories Burned

    Total number of calories burned during the assigned condition

    Measured: Day 1

  7. Number of Active Minutes

    Total number of active minutes during the assigned condition

    Measured: Day 1

  8. Changes in Executive Functioning

    The Trail Making Test (TMT) will be used to calculate changes in executive function (Arbuthnott \& Frank, 2000; Kortte et al., 2002; Reitan, 1956). Participants will be required to draw lines connecting different scattered numbers (Part A) and scattered numbers and letters (Part B). If the test can not be completed in 5-minutes it will be stopped. The more errors a person makes, and the longer a person takes, indicate poorer outcomes for executive function and changes in this measure will be calculated from pre- to post-activity.

    Measured: Day 1

  9. Changes in Working Memory Capacity

    The Backward Digits Span (BDT, Lamar et al., 2007) measures an individual's working memory capacity and is comprised of 21 trials where participants will need to recall 3, 4, and 5-digit spans. The more numbers a person can correctly recall the better their working memory. Changes in this measure, from pre- to post-activity, will be calculated

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start1 Sep 2024
  3. Primary completion22 Oct 2025
  4. Study completion22 Oct 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Three group, randomized trial
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213388
Sponsor's protocol ID
PRO-2023-123
Acronym
IVRTE
Status last verified
Jan 2026
First submitted
19 Feb 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers can request deidentified data sets after the research team has published all planned analyses related to this research.

Questions about this trial

What is this clinical trial studying?

A study testing VRPA and Treadmill in people with Control and Virtual Reality Physical Activity, run by Rowan 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jan 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pace of participant recruitment (time frame: Up to 24 months). The study lists 3 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 NCT07213388.

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 Jan 2026.

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