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临床试验/NCT04221139
NCT04221139已完成不适用

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

Indiana University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Ratings of perceived exertion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Ages 18 to 30 years old.

排除标准

  • •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.

研究组 & 干预措施

Healthy young adults

Experimental

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

干预措施: Virtual Reality games (Behavioral)

结局指标

主要结局

Ratings of perceived exertion

时间窗: 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.

Arm percentage of time spent in moderate to vigorous physical activity

时间窗: 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.

Average percentage of heart rate reserve during game play

时间窗: 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.

Whole body percentage of time spent in moderate to vigorous physical activity

时间窗: 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.

Whole body Percentage of time spent in sedentary time

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Naugle, PhD

Assistant Professor

Indiana University

研究点 (1)

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