Physical ActivityNCT04221139
Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity
A study testing Virtual Reality games in people with Physical Activity, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate physical activity intensity levels, enjoyment, and pain perception during virtual reality (VR) active games in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Virtual Reality games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 17 Feb 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 to 30 years old.
Who cannot join
- Prior or current events with motion sickness or claustrophobia
- Any acute or chronic pain condition
- If "yes" is answered on any of the general health questions on the Physical Activity Readiness Questionnaire (PAR-Q+ 2019 version) and the subsequent answer of "yes" on any follow-up question on the about any present medical condition will exclude a participant. The initial seven questions on the form include the following with more extensive follow-up questions in the event that any are answered with "yes."
- If participant's doctor has ever said that he/she has a heart condition and that he/she should only do physical activity recommended by a doctor
- Pain in chest when doing physical activity
- In past month, chest pain when not doing physical activity
Show all 13Show fewer
- If participant has ever lost balance because of dizziness or has ever lost consciousness
- Bone or joint problem that could be made worse by change in physical activity
- Currently on prescribed drugs for blood pressure or heart condition.
- If the participant knows of any other reason why he/she should not do physical activity.
- Session exclusion criteria:
- Severe uncontrolled hypertension: resting Systolic blood pressure > 180mmHg, resting diastolic blood pressure> 99mmhg
- Participating in vigorous exercise at least 12 hours prior to study sessions, eating at least 1 hour prior to each session, and smoking, consuming alcohol for 24 hours, and caffeine, and analgesic medications on the day of the session prior to the session.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Fitness and Sport
Indianapolis, Indiana, 46202
About this study
The purpose of this research study is to evaluate physical activity intensity levels, enjoyment, and pain perception during virtual reality (VR) active games in healthy young adults.
Read the detailed description
Enrolled participants will complete four sessions: the first session including the informed consent process and one experimental game, and sessions 2-4 being devoted to one experimental game per session.
Screening and enrollment (Session 1 only): All participants will be asked to read and sign an Informed Consent Form (ICF) and a copy of the ICF will be given to the participant to keep for their records. Following the ICF process, participants will be given the Physical Activity Readiness-Questionnaire Plus (2019 version), a demographic questionnaire, and the International Physical Activity Questionnaire (IPAQ) to fill out. Inclusion and exclusion criteria will be assessed and eligibility will be determined.
Familiarization of pain test and VR system (Session 1 only):
Participants will undergo a familiarization with the pressure pain threshold (PPT) test to measure pain sensitivity. The PPT test will be performed as practice on the participants' non-dominant forearm and thigh three times. Following PPT familiarization, participants will be shown the HTC Vive system, which includes a head-mounted display system and two handheld controllers. The HTC Vive system comes with a tutorial program which exposes the user to the basic functions of the VR system. Each participant will be fitted with the headset and follow the tutorial for movement/system familiarization.
Experimental Protocol (All sessions): In each session participants will play one of the following four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk. The order of the games played in Sessions 1 - 4 will be randomized and counterbalanced. Following the familiarization via the tutorial program (only Session 1), participants will be introduced to one of the games (which will be randomized). A verbal description of the game followed by a visual demonstration will be conducted by the researcher for the participant to observe. The participant will then play the game for approximately 10 minutes for familiarization. After 10 minutes, the participants will be asked to stop playing and sit in a resting position to allow for a proper return to resting heart rate.
Participants will wear accelerometers on the hip and arm to measure physical activity behavior during game play. Participants will also wear heart rate monitors during game play. The participants will then play the game for 15 minutes. Every 5 minutes the participant will be asked to rate their exertion using the Borg 6-20 Ratings of Perceived Exertion (RPE) scale. After 15 minutes of game play, the pressure pain thresholds will be administered on the leg and forearm. The participant will then be allowed/assisted in removing the VR headset and will be asked to rate their level of enjoyment using an 11-point Visual Analog Scale. The next session will be scheduled with the participant. Session 1 is expected to last 1.5 hours and sessions 2 through 4 will last approximately 1 hour.
- Conditions
- Physical Activity
- Being tested
- Virtual Reality games
- Keywords
- Virtual reality, active gaming, Physical activity, exercise-induced hypoalgesia
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality gamesBehavioural
Participants will play the following four virtual reality games for 15 minutes each: Beat Saber, Holopoint, Hot Squat, and Relax Walk.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young adults | Experimental | Healthy young adults will play four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk. Receives: Behavioral: Virtual Reality games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of perceived exertion
Ratings of Perceived Exertion Borg Scale. The minimum value is 6, indicating no exertion. The maximum value is 20, indicating maximal exertion.
Measured: This measure will be assessed immediately after playing the virtual reality games
Whole body percentage of time spent in moderate to vigorous physical activity
Participants will wear an accelerometer on the hip during the virtual reality games. Activity count cut points can identify the amount of time spent in moderate to vigorous physical activity during game play.
Measured: This measure will be assessed during the 15 minutes of each virtual reality game play.
Arm percentage of time spent in moderate to vigorous physical activity
Participants will wear an accelerometer on the dominant arm during the virtual reality games. Activity count cut points can identify the amount of time spent in moderate to vigorous physical activity during game play.
Measured: This measure will be assessed during the 15 minutes of each virtual reality game play.
Whole body Percentage of time spent in sedentary time
Participants will wear an accelerometer on the hip during the virtual reality games. Activity count cut points can identify the amount of time spent in sedentary behavior during game play.
Measured: This measure will be assessed during the 15 minutes of each virtual reality game play.
Arm percentage of time spent in sedentary time
Participants will wear an accelerometer on the dominant arm during the virtual reality games. Activity count cut points can identify the amount of time spent in sedentary behavior during game play.
Measured: This measure will be assessed during the 15 minutes of each virtual reality game play.
Average percentage of heart rate reserve during game play
Participants will be fitted with a Polar heart rate monitor (Polar Electro) at the beginning of each experimental session and will be monitored during gameplay. Heart rate values will be used to calculate percentages of heart rate reserve (HRR) for interpreting intensity levels.
Measured: This measure will be assessed during the 15 minutes of each virtual reality game play.
Secondary outcomes (3)
Enjoyment
participants will be asked to complete an 11-point visual analogue scale indicating their level of enjoyment while playing the active game, with 0 indicating no enjoyment and 10 indicating the most enjoyment one could experience.
Measured: This measure will be assessed immediately after each virtual reality game is played.
Enjoyment during game play
Participants will complete the modified Physical Activity Enjoyment Scale (PACES), which includes Likert-style questions asking about enjoyment during physical activity. The score ranges from 5 to 35, with a higher value indicating higher enjoyment.
Measured: This measure will be assessed immediately after each virtual reality game is played.
Pressure pain sensitivity
Using a hand-held, clinical grade pressure algometer (Wagner Instruments, Greenwich, CT), pressure will be applied to the dominant forearm and thigh. Pressure will increase at a rate of about 1kg/s until the subject first reports feeling pain.
Measured: This measure will be assessed before the virtual reality games and immediately after the virtual reality games are played.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Feb 2020
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
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 Physical ActivityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Naugle, PhD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221139
- Sponsor's protocol ID
- 1907886495
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evans E, Naugle KE, Kaleth AS, Arnold B, Naugle KM. Physical Activity Intensity, Perceived Exertion, and Enjoyment During Head-Mounted Display Virtual Reality Games. Games Health J. 2021 Oct;10(5):314-320. doi: 10.1089/g4h.2021.0036. Epub 2021 Aug 27.
PubMed 34449262
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity
- ClinicalTrials.gov ID
- NCT04221139
- Acronym / sponsor ID
- 1907886495
- Conditions
- Physical Activity
- Keywords
- Virtual reality, active gaming, Physical activity, exercise-induced hypoalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 9 Jan 2020 (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.
The purpose of this research study is to evaluate physical activity intensity levels, enjoyment, and pain perception during virtual reality (VR) active games in healthy young adults.
Detailed description
Enrolled participants will complete four sessions: the first session including the informed consent process and one experimental game, and sessions 2-4 being devoted to one experimental game per session.
Screening and enrollment (Session 1 only): All participants will be asked to read and sign an Informed Consent Form (ICF) and a copy of the ICF will be given to the participant to keep for their records. Following the ICF process, participants will be given the Physical Activity Readiness-Questionnaire Plus (2019 version), a demographic questionnaire, and the International Physical Activity Questionnaire (IPAQ) to fill out. Inclusion and exclusion criteria will be assessed and eligibility will be determined.
Familiarization of pain test and VR system (Session 1 only):
Participants will undergo a familiarization with the pressure pain threshold (PPT) test to measure pain sensitivity. The PPT test will be performed as practice on the participants' non-dominant forearm and thigh three times. Following PPT familiarization, participants will be shown the HTC Vive system, which includes a head-mounted display system and two handheld controllers. The HTC Vive system comes with a tutorial program which exposes the user to the basic functions of the VR system. Each participant will be fitted with the headset and follow the tutorial for movement/system familiarization.
Experimental Protocol (All sessions): In each session participants will play one of the following four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk. The order of the games played in Sessions 1 - 4 will be randomized and counterbalanced. Following the familiarization via the tutorial program (only Session 1), participants will be introduced to one of the games (which will be randomized). A verbal description of the game followed by a visual demonstration will be conducted by the researcher for the participant to observe. The participant will then play the game for approximately 10 minutes for familiarization. After 10 minutes, the participants will be asked to stop playing and sit in a resting position to allow for a proper return to resting heart rate.
Participants will wear accelerometers on the hip and arm to measure physical activity behavior during game play. Participants will also wear heart rate monitors during game play. The participants will then play the game for 15 minutes. Every 5 minutes the participant will be asked to rate their exertion using the Borg 6-20 Ratings of Perceived Exertion (RPE) scale. After 15 minutes of game play, the pressure pain thresholds will be administered on the leg and forearm. The participant will then be allowed/assisted in removing the VR headset and will be asked to rate their level of enjoyment using an 11-point Visual Analog Scale. The next session will be scheduled with the participant. Session 1 is expected to last 1.5 hours and sessions 2 through 4 will last approximately 1 hour.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young adults | Experimental | Behavioral: Virtual Reality gamesHealthy young adults will play four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ages 18 to 30 years old.
Key exclusion criteria (13 listed)
- Prior or current events with motion sickness or claustrophobia
- Any acute or chronic pain condition
- If "yes" is answered on any of the general health questions on the Physical Activity Readiness Questionnaire (PAR-Q+ 2019 version) and the subsequent answer of "yes" on any follow-up question on the about any present medical condition will exclude a participant. The initial seven questions on the form include the following with more extensive follow-up questions in the event that any are answered with "yes."
- Severe uncontrolled hypertension: resting Systolic blood pressure > 180mmHg, resting diastolic blood pressure> 99mmhg
- Participating in vigorous exercise at least 12 hours prior to study sessions, eating at least 1 hour prior to each session, and smoking, consuming alcohol for 24 hours, and caffeine, and analgesic medications on the day of the session prior to the session.
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 Reality gamesParticipants will play the following four virtual reality games for 15 minutes each: Beat Saber, Holopoint, Hot Squat, and Relax Walk. | Behavioural | Healthy young adults |
Primary outcome
Ratings of perceived exertion
Time frame: This measure will be assessed immediately after playing the virtual reality games
Ratings of Perceived Exertion Borg Scale. The minimum value is 6, indicating no exertion. The maximum value is 20, indicating maximal exertion.
Whole body percentage of time spent in moderate to vigorous physical activity
Time frame: This measure will be assessed during the 15 minutes of each virtual reality game play.
Participants will wear an accelerometer on the hip during the virtual reality games. Activity count cut points can identify the amount of time spent in moderate to vigorous physical activity during game play.
Arm percentage of time spent in moderate to vigorous physical activity
Time frame: This measure will be assessed during the 15 minutes of each virtual reality game play.
Participants will wear an accelerometer on the dominant arm during the virtual reality games. Activity count cut points can identify the amount of time spent in moderate to vigorous physical activity during game play.
Whole body Percentage of time spent in sedentary time
Time frame: This measure will be assessed during the 15 minutes of each virtual reality game play.
Participants will wear an accelerometer on the hip during the virtual reality games. Activity count cut points can identify the amount of time spent in sedentary behavior during game play.
Arm percentage of time spent in sedentary time
Time frame: This measure will be assessed during the 15 minutes of each virtual reality game play.
Participants will wear an accelerometer on the dominant arm during the virtual reality games. Activity count cut points can identify the amount of time spent in sedentary behavior during game play.
Average percentage of heart rate reserve during game play
Time frame: This measure will be assessed during the 15 minutes of each virtual reality game play.
Participants will be fitted with a Polar heart rate monitor (Polar Electro) at the beginning of each experimental session and will be monitored during gameplay. Heart rate values will be used to calculate percentages of heart rate reserve (HRR) for interpreting intensity levels.
3 secondary outcomes
Enjoyment
Time frame: This measure will be assessed immediately after each virtual reality game is played.
Enjoyment during game play
Time frame: This measure will be assessed immediately after each virtual reality game is played.
Pressure pain sensitivity
Time frame: This measure will be assessed before the virtual reality games and immediately after the virtual reality games are played.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 34449262Evans E, Naugle KE, Kaleth AS, Arnold B, Naugle KM. Physical Activity Intensity, Perceived Exertion, and Enjoyment During Head-Mounted Display Virtual Reality Games. Games Health J. 2021 Oct;10(5):314-320. doi: 10.1089/g4h.2021.0036. Epub 2021 Aug 27.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 games in people with Physical Activity, run by Indiana 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 1 inclusion and 13 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 24 Jan 2024. 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?
Ratings of perceived exertion (time frame: This measure will be assessed immediately after playing the virtual reality games). The study lists 6 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 NCT04221139, 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 24 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.