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

Primary Purpose

Physical Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality games
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physical Activity focused on measuring Virtual reality, active gaming, Physical activity, exercise-induced hypoalgesia

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Institute of Fitness and SportRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy young adults

Arm Description

Healthy young adults will play four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 6, 2020
Last Updated
April 26, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04221139
Brief Title
Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity
Official Title
Virtual Reality: Its Effect on Physical Activity Intensity and Pain Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity
Keywords
Virtual reality, active gaming, Physical activity, exercise-induced hypoalgesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy young adults
Arm Type
Experimental
Arm Description
Healthy young adults will play four virtual reality games: Beat Saber, Holopoint, Hot Squat, and Relax Walk.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality games
Intervention Description
Participants will play the following four virtual reality games for 15 minutes each: Beat Saber, Holopoint, Hot Squat, and Relax Walk.
Primary Outcome Measure Information:
Title
Ratings of perceived exertion
Description
Ratings of Perceived Exertion Borg Scale. The minimum value is 6, indicating no exertion. The maximum value is 20, indicating maximal exertion.
Time Frame
This measure will be assessed immediately after playing the virtual reality games
Title
Whole body percentage of time spent in moderate to vigorous physical activity
Description
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.
Time Frame
This measure will be assessed during the 15 minutes of each virtual reality game play.
Title
Arm percentage of time spent in moderate to vigorous physical activity
Description
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.
Time Frame
This measure will be assessed during the 15 minutes of each virtual reality game play.
Title
Whole body Percentage of time spent in sedentary time
Description
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.
Time Frame
This measure will be assessed during the 15 minutes of each virtual reality game play.
Title
Arm percentage of time spent in sedentary time
Description
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.
Time Frame
This measure will be assessed during the 15 minutes of each virtual reality game play.
Title
Average percentage of heart rate reserve during game play
Description
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.
Time Frame
This measure will be assessed during the 15 minutes of each virtual reality game play.
Secondary Outcome Measure Information:
Title
Enjoyment
Description
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.
Time Frame
This measure will be assessed immediately after each virtual reality game is played.
Title
Enjoyment during game play
Description
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.
Time Frame
This measure will be assessed immediately after each virtual reality game is played.
Title
Pressure pain sensitivity
Description
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.
Time Frame
This measure will be assessed before the virtual reality games and immediately after the virtual reality games are played.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly M Naugle, PhD
Phone
3172740601
Email
kmnaugle@iupui.edu
Facility Information:
Facility Name
National Institute of Fitness and Sport
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly M Naugle
Phone
317-418-4614
Ext
3174184614
Email
kmnaugle@iupui.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
34449262
Citation
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.
Results Reference
derived

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

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