NCT04221139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

January 6, 2020

Last Update Submit

January 23, 2024

Conditions

Keywords

Virtual realityactive gamingPhysical activityexercise-induced hypoalgesia

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Enjoyment

    This measure will be assessed immediately after each virtual reality game is played.

  • Enjoyment during game play

    This measure will be assessed immediately after each virtual reality game is played.

  • Pressure pain sensitivity

    This measure will be assessed before the virtual reality games and immediately after the virtual reality games are played.

Study Arms (1)

Healthy young adults

EXPERIMENTAL

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

Behavioral: Virtual Reality games

Interventions

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

Healthy young adults

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18 to 30 years old.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Fitness and Sport

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

February 1, 2020

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations