Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396182
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Effect of Virtual Reality Exercise Versus Aerobic Training on Performance and Endurance in Physical Therapy Students
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Virtual Reality Exercise Versus Aerobic Training on Performance and Endurance in Physical Therapy Students
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low levels of physical activity and sedentary lifestyle have become a major public health problem contributing to the prevalence of many chronic diseases and reduced life expectancy worldwide and also increase the risk of heart disease stroke hypertension type 2 diabetes dementia depression excessive weight gain and breast and colon cancer Physical activity improves functional health and quality of life Iva Sklempe Kokic et al 2019
In Middle East Insufficient physical activity and sedentary behavior are key risk factors for obesity and other diseases leading to premature mortality Regular physical activity can improve self-esteem cognitive performance and academic achievement in young people Sonia Chaabane et al 2020
University students due to the time spent in classes studying or in front of computers form part of the population most at risk of adopting sedentary behavior Different studies have shown that the transition to university studies is usually associated to a decrease in physical activity and an increase in sedentary behavior as a result of lifestyle changes as well as psychosocial factors Cotton et al 2016
Exercise is often perceived as boring and hard thereby causing adults and students shy away from physical activity -related behaviors after long days of work andor school Instead individuals are more interested in leisure activities such as video games Thus the combination of video games and engaging in physical activity eg virtual reality -integrated exercise may
trigger their interest and improve their physical activity behavior Jiali Qian et al 2020
So this trial aim to find if the virtual reality exercise as a new modality will make sedentary physical student more interest to adherent to exercise than conventional aerobic training so makes them more physically active which will enhance their academic performance and endurance
In Middle East Insufficient physical activity and sedentary behavior are key risk factors for obesity and other diseases leading to premature mortality Regular physical activity can improve self-esteem cognitive performance and academic achievement in young people Sonia Chaabane et al 2020
University students due to the time spent in classes studying or in front of computers form part of the population most at risk of adopting sedentary behavior Different studies have shown that the transition to university studies is usually associated to a decrease in physical activity and an increase in sedentary behavior as a result of lifestyle changes as well as psychosocial factors Cotton et al 2016
Exercise is often perceived as boring and hard thereby causing adults and students shy away from physical activity -related behaviors after long days of work andor school Instead individuals are more interested in leisure activities such as video games Thus the combination of video games and engaging in physical activity eg virtual reality -integrated exercise may
trigger their interest and improve their physical activity behavior Jiali Qian et al 2020
So this trial aim to find if the virtual reality exercise as a new modality will make sedentary physical student more interest to adherent to exercise than conventional aerobic training so makes them more physically active which will enhance their academic performance and endurance
Detailed Description:
This study will design to compare the effect of Virtual Reality Exercise versus aerobic training on performance and endurance in physical therapy students
I-Subjects
This study will be carried out on sixty physical therapy students female-class I obesity will selected from faculty of physical therapy all participants will be randomly assigned to two equal group in number their ages will be ranged from 18-25 years
Ethical consideration
The purpose nature and potential risks of the study will explain to participants All participants will sign a consent form prior to participation in the study as shown in appendix I no of approval
Inclusion criteria
The subject selection will be according to the following criteria
Age between 18 and 25 years
Female only will participate in the study
Class I obesity Body mass index is 300 to 349
No diseasesconditions preventing physical activity participation
Exclusion criteria
The potential participants will be excluded if they meet one of the following criteria
Have any cardiovascular cerebrovascular or neurological diseases
Have any attention disorders or physical disability
Previously played the virtual reality exercise that will applied in this thesis
The subjects participating in the study will be randomly assigned to two equal group in number
- Group A Study group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min
cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
- Group B Control group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of cycling session by traditional stationary bike
II-Materials
1 Evaluation tools
1 Heightweight chart
To calculate body mass index as shown in appendix II Karoline Hood et al 2019
2 pulse oximeter To measure oxygen saturation and HR before and after each session And monitor HR during session
Digital Fingertip Pulse Oximeter LED Display Blood Oxygen and HR Brand CONTEC Manufacturer Number 2724295057898 made in china
3 The 6-min walk test 6MWT
participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance 6MWD measured in meters PriyaAgarwala et al 2020
4 Measure estimated vo2 max
At first Determine resting heart rate by pulse oximeter Then Calculate maximum heart rate by subtract age from 220 Then calculate estimated VO2 max by formula
VO2 max 15 x HRmaxHRrest
The units for VO2 max are milliliters of oxygen per kilogram of body weight per minute mLkgmin Davies et al 2020
5 The McArdle step test OR Queens college step test QCT
The participant steps up and down on the platform at a rate of 22 steps per minute for females The participants are to step using a four-step cadence up-up-down-down for 3 minutes The participant stops immediately on completion of the test and the heart beats are counted for 15 seconds from 5-20 seconds of recovery Multiply this 15 second reading by 4 will give the beats per minute bpm value to be used in the calculation below an estimation of VO2max can be calculated from the test results using this formula A rating can be determined using the VO2max norms
women VO2maxmlkgmin 6581 - 01847 x heart rate bpm Çağtay Maden et al 2022
6 The Perceived Stress Scale PSS
Participant ask to indicate how often he felt or thought during the last month Ten questions for each question participant choose from the following alternatives 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often as shown in appendix III Miguel A Vallejo et al 2018
7 The Ardell Wellness Stress Test
In this scale participant ask to rate satisfaction with each of the following items 0 Indifferent 1 Mildly happy 2 Very happy 3 Ecstatic -1 Mildly disappointed - 2 Very disappointed - 3 Completely dismayed as shown in appendix IV Daksh Sharma et al 2018
8 Stress Coping Resources Inventory A Self-Assessment
participant ask to answer questions relate to factors most closely associated with the capacity to cope successfully with stress Participant ask to Circle the letter which lists the option that he choose and Answer each question as honestly as possible A perfect score will be 4 as shown in appendix V Jesús de la Fuente et al 2018
2 Therapeutic tools
1 Fully Immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
Oculus Quest virtual reality VR headset with hand controller and software using Unreal Engine 420 3ds Max 2019 and Substance Designer 2018 software made in Japan
2 Traditional stationary bike
Traditional stationary cycling will complete on a Spirit Fitness XBU55 Upright Bike Spirit Fitness Jonesboro AR made in china
III-Methods
The intervention will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up will precede each session and 10-min resting phase after each session with the actual time of each session is 30 minute Chao Lan et al 2022
Participants will require to continuously pedal while maintaining an HR between 65 and 85 of their age predicted maximum HR-tracked using the HR monitor in pulse oximeter Daniel et al 2020
The participants will divide into two group equal in number
Group A Study group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
- virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
The VR cycling session utilized the VZFIT VR Exercise Bike VZFIT Cambridge MA which syncs with the Sony PlayStation 4 and PlayStation VR headset Sony Tokyo Japan via integrated sensors Participants who wore prescription glasses were allowed to wear their glasses during this session and a trained research assistant adjusted the VR headset comfortably over the glasses to ensure all participants had optimal vision during gameplay The associated VZFIT Arcade Game suite houses numerous VR mini-games within which Race Car and Le Tour-virtual racecar and cycling racing games respectively-were selected for play These games were selected as preliminary pilot trials indicated these games to be most intense Players maneuvered during VR gameplay by pedaling and steering their virtual character by leaning their bodies left and right Daniel et al 2020
Group B Control group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of cycling session by traditional stationary bike
Cycling by traditional stationary bike
Participants will require to continuously pedal using the pulse oximeter for HR monitor Research personnel monitored participants during the session adjusting pedal-resistance to ensure that the participants stayed within their target HR zone Daniel et al 2020
Statistical procedures
Statistical Package for Social Sciences SPSS
Descriptive statistics
In this study the descriptive statistics the mean and the standard deviation will be calculated for all subjects in the two groups of the study to determine the homogeneity of the groups
Analytical statistics
Comparison will make by students t-test to compare the variables between the two groups of the study Paired t-test will use to compare before and after treatment in the same group A value of p005 will be considered statistically significant Prabhaker Mishra et al 2019
I-Subjects
This study will be carried out on sixty physical therapy students female-class I obesity will selected from faculty of physical therapy all participants will be randomly assigned to two equal group in number their ages will be ranged from 18-25 years
Ethical consideration
The purpose nature and potential risks of the study will explain to participants All participants will sign a consent form prior to participation in the study as shown in appendix I no of approval
Inclusion criteria
The subject selection will be according to the following criteria
Age between 18 and 25 years
Female only will participate in the study
Class I obesity Body mass index is 300 to 349
No diseasesconditions preventing physical activity participation
Exclusion criteria
The potential participants will be excluded if they meet one of the following criteria
Have any cardiovascular cerebrovascular or neurological diseases
Have any attention disorders or physical disability
Previously played the virtual reality exercise that will applied in this thesis
The subjects participating in the study will be randomly assigned to two equal group in number
- Group A Study group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min
cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
- Group B Control group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of cycling session by traditional stationary bike
II-Materials
1 Evaluation tools
1 Heightweight chart
To calculate body mass index as shown in appendix II Karoline Hood et al 2019
2 pulse oximeter To measure oxygen saturation and HR before and after each session And monitor HR during session
Digital Fingertip Pulse Oximeter LED Display Blood Oxygen and HR Brand CONTEC Manufacturer Number 2724295057898 made in china
3 The 6-min walk test 6MWT
participant is asked to walk as far as possible along a 30-m minimally trafficked corridor for a period of 6 min with the primary outcome measure being the 6-min walk distance 6MWD measured in meters PriyaAgarwala et al 2020
4 Measure estimated vo2 max
At first Determine resting heart rate by pulse oximeter Then Calculate maximum heart rate by subtract age from 220 Then calculate estimated VO2 max by formula
VO2 max 15 x HRmaxHRrest
The units for VO2 max are milliliters of oxygen per kilogram of body weight per minute mLkgmin Davies et al 2020
5 The McArdle step test OR Queens college step test QCT
The participant steps up and down on the platform at a rate of 22 steps per minute for females The participants are to step using a four-step cadence up-up-down-down for 3 minutes The participant stops immediately on completion of the test and the heart beats are counted for 15 seconds from 5-20 seconds of recovery Multiply this 15 second reading by 4 will give the beats per minute bpm value to be used in the calculation below an estimation of VO2max can be calculated from the test results using this formula A rating can be determined using the VO2max norms
women VO2maxmlkgmin 6581 - 01847 x heart rate bpm Çağtay Maden et al 2022
6 The Perceived Stress Scale PSS
Participant ask to indicate how often he felt or thought during the last month Ten questions for each question participant choose from the following alternatives 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often as shown in appendix III Miguel A Vallejo et al 2018
7 The Ardell Wellness Stress Test
In this scale participant ask to rate satisfaction with each of the following items 0 Indifferent 1 Mildly happy 2 Very happy 3 Ecstatic -1 Mildly disappointed - 2 Very disappointed - 3 Completely dismayed as shown in appendix IV Daksh Sharma et al 2018
8 Stress Coping Resources Inventory A Self-Assessment
participant ask to answer questions relate to factors most closely associated with the capacity to cope successfully with stress Participant ask to Circle the letter which lists the option that he choose and Answer each question as honestly as possible A perfect score will be 4 as shown in appendix V Jesús de la Fuente et al 2018
2 Therapeutic tools
1 Fully Immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
Oculus Quest virtual reality VR headset with hand controller and software using Unreal Engine 420 3ds Max 2019 and Substance Designer 2018 software made in Japan
2 Traditional stationary bike
Traditional stationary cycling will complete on a Spirit Fitness XBU55 Upright Bike Spirit Fitness Jonesboro AR made in china
III-Methods
The intervention will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up will precede each session and 10-min resting phase after each session with the actual time of each session is 30 minute Chao Lan et al 2022
Participants will require to continuously pedal while maintaining an HR between 65 and 85 of their age predicted maximum HR-tracked using the HR monitor in pulse oximeter Daniel et al 2020
The participants will divide into two group equal in number
Group A Study group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
- virtual reality cycling by fully immersive Head-Mounted Display virtual reality Oculus Quest virtual reality VR headset with hand controller
The VR cycling session utilized the VZFIT VR Exercise Bike VZFIT Cambridge MA which syncs with the Sony PlayStation 4 and PlayStation VR headset Sony Tokyo Japan via integrated sensors Participants who wore prescription glasses were allowed to wear their glasses during this session and a trained research assistant adjusted the VR headset comfortably over the glasses to ensure all participants had optimal vision during gameplay The associated VZFIT Arcade Game suite houses numerous VR mini-games within which Race Car and Le Tour-virtual racecar and cycling racing games respectively-were selected for play These games were selected as preliminary pilot trials indicated these games to be most intense Players maneuvered during VR gameplay by pedaling and steering their virtual character by leaning their bodies left and right Daniel et al 2020
Group B Control group Thirty participant The program of treatment will be 3 times a week lasting for 8 weeks A standardized 5- min warm-up phase will precede each session and 10-min cooling down phase after each session with the actual time of each session is 30 minute 30 minutes of cycling session by traditional stationary bike
Cycling by traditional stationary bike
Participants will require to continuously pedal using the pulse oximeter for HR monitor Research personnel monitored participants during the session adjusting pedal-resistance to ensure that the participants stayed within their target HR zone Daniel et al 2020
Statistical procedures
Statistical Package for Social Sciences SPSS
Descriptive statistics
In this study the descriptive statistics the mean and the standard deviation will be calculated for all subjects in the two groups of the study to determine the homogeneity of the groups
Analytical statistics
Comparison will make by students t-test to compare the variables between the two groups of the study Paired t-test will use to compare before and after treatment in the same group A value of p005 will be considered statistically significant Prabhaker Mishra et al 2019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None