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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04221139
Study type Interventional
Source Indiana University
Contact
Status Completed
Phase N/A
Start date February 1, 2020
Completion date February 17, 2023

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