Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity

Physical Activity Clinical Trial

Official title:

Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221139
• Other study ID #: 1907886495
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 17, 2023

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Ages 18 to 30 years old.

Exclusion Criteria:

• 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
• 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.

Related Conditions & MeSH terms

• Hypersensitivity
• Physical Activity

Intervention

Behavioral:
• Virtual Reality games
Participants will play the following four virtual reality games for 15 minutes each: Beat Saber, Holopoint, Hot Squat, and Relax Walk.

Locations

Country	Name	City	State
United States	National Institute of Fitness and Sport	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This measure will be assessed immediately after playing the virtual reality games
Primary	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.	This measure will be assessed during the 15 minutes of each virtual reality game play.
Primary	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.	This measure will be assessed during the 15 minutes of each virtual reality game play.
Primary	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.	This measure will be assessed during the 15 minutes of each virtual reality game play.
Primary	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.	This measure will be assessed during the 15 minutes of each virtual reality game play.
Primary	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.	This measure will be assessed during the 15 minutes of each virtual reality game play.
Secondary	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.	This measure will be assessed immediately after each virtual reality game is played.
Secondary	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.	This measure will be assessed immediately after each virtual reality game is played.
Secondary	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.	This measure will be assessed before the virtual reality games and immediately after the virtual reality games are played.