xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05985096</url>
    </required_header>
    <id_info>
      <org_study_id>A-2325</org_study_id>
      <nct_id>NCT05985096</nct_id>
    </id_info>
    <brief_title>The Effects of Virtual Reality Education on Balance, Depression, Anxiety and Stress Parameters</brief_title>
    <official_title>The Effects of Virtual Reality Education on Balance, Depression, Anxiety and Stress Parameters in Healthy Young Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>T.C. ORDU ÜNİVERSİTESİ</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute&#xD;
        (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289&#xD;
        people, which is 15.3% of the total population. Considering the proportion of young&#xD;
        population in our country, the evaluation of physical activity level has an important place,&#xD;
        while the proportion of female university students who achieved sufficient physical activity&#xD;
        level according to the scoring of the International Physical Activity Questionnaire (UFAA)&#xD;
        was 8.5%, while the proportion of male students was 28.1% in previous studies (Arslan 2015).&#xD;
        ).&#xD;
  &#xD;
        We know from previous studies that achieving an adequate level of physical activity directly&#xD;
        reduces the body mass index and indirectly reduces the cardiovascular risk associated with&#xD;
        obesity (Swift 2018). Exercise reduces depression levels and the effects of depression.&#xD;
        Although the neural mechanisms are not very clear, there are some predictions for physical&#xD;
        exercise to reduce the level of depression (Gujral 2017). The hippocampus is an important&#xD;
        cognitive and sensory centre, and it has been reported that hippocampal volume decreases by&#xD;
        5% in depressed individuals (Cole 2011). Hippocampal volume has been reported to increase&#xD;
        rapidly with exercise (Bugg 2012).&#xD;
  &#xD;
        The brain region most affected in major depressive disorder is the prefrontal cortex. After&#xD;
        the prefrontal cortex is affected, symptoms such as negative affect and learned helplessness&#xD;
        appear (Pizagalli 2021). Experimental studies in mice have shown that treadmill training&#xD;
        creates new synaptic pathways in the prefrontal cortex and hippocampus (Mu 2022).&#xD;
  &#xD;
        Another brain region affected by depression is the corpus striatum. Loss of corpus striatum&#xD;
        volume is observed in patients with major depression (Zhang 2020). The volume of the corpus&#xD;
        striatum modulates when physical exercise reaches a sufficient level. (Rotttensteiner 2015).&#xD;
  &#xD;
        Adequate levels of physical activity not only reduce depression, but also prevent neural&#xD;
        dysfunction that can occur as a result of depression. However, young people do not get enough&#xD;
        exercise. Based on this fact, we believe that it is necessary to use 3D virtual reality&#xD;
        applications to increase physical activity levels and exercise motivation.&#xD;
  &#xD;
        The aim of our study is to investigate the effect of virtual reality training on balance,&#xD;
        depression, anxiety and stress parameters in healthy young people.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Our work will last 6 weeks and is planned as exercise for 1 hour a day, 2 days a week.&#xD;
  &#xD;
        Group 1: The control group will do individual exercise. The monitoring of the physical&#xD;
        exercises will be done with video recordings.&#xD;
  &#xD;
        Physical exercises Stick exercises: Shoulder stick (wand) exercises aim to perform shoulder&#xD;
        range of motion exercises by supporting the sore arm with a solid arm. Use the stick to make&#xD;
        forward, side, backward, outward and inward movements as shown in the picture. Count to 5 at&#xD;
        the end of each movement and return to the beginning (Puendgsuwan 2008).&#xD;
  &#xD;
        Codman exercises: Step forward with one foot and lean forward on a stable surface such as a&#xD;
        table. Release your arm using the weight: move it back and forth like a pendulum. c) Circle&#xD;
        clockwise and counterclockwise (Cunningham 2020).&#xD;
  &#xD;
        Squat exercises: With feet open at shoulder height, the person's back is against the wall and&#xD;
        positioned 10 cm in front of the wall. The rolling pin on the shoulder is grasped with the&#xD;
        hands. The person faces forward. The movement is performed by bending the hip and knee joints&#xD;
        without disturbing the straightness of the back and without touching the wall. Then return to&#xD;
        starting position, keeping the spine straight and extending the hip and knee joints. Perform&#xD;
        3 sets of 10 repetitions (Kubo 2019).&#xD;
  &#xD;
        Tandem walking exercise: A straight line is drawn on the floor. From the person, 10 steps are&#xD;
        taken to follow this straight line with the heel of the front foot to the tip of the back&#xD;
        foot. 3 sets of eyes open and 3 sets of eyes closed (Cruz 2021).&#xD;
  &#xD;
        Group 2: Virtual reality group. People in this group will be expected to meet their physical&#xD;
        activity levels with Racket, Climb, Acron, Skiing, Cycling games using the Oculus Quest 2 VR&#xD;
        goggles platform.&#xD;
  &#xD;
        Virtual reality games Racket: Nx is a new type of game in VR that pushes the boundaries of&#xD;
        what you can do with a racket and a ball. The game takes place inside a giant glass dome, the&#xD;
        walls of which are lit up with targets that you have to destroy with the cannon. But this is&#xD;
        no ordinary ball. If you hit it hard, it will crash into a wall, roll over, and bulldozers&#xD;
        will crush everything in its path. Use the racket's hammer beam to retreat or aim the next&#xD;
        hit exactly where you want it. Targets appear in waves and the aim is to destroy them all&#xD;
        before you run out of energy. But targets aren't the only thing in the arena. That's why you&#xD;
        need to hit quickly and accurately. But in this game, the aim is to teach you how to control&#xD;
        the ball perfectly. It is an alternative to coordination exercises.&#xD;
  &#xD;
        Climbing: The aim of this game is to simulate climbing. It can be used as an alternative to&#xD;
        strengthening the upper limbs. From exploring mountain environments to scaling urban&#xD;
        environments, the game is also designed to have the dual effect of feeling the excitement of&#xD;
        climbing without ropes and experiencing the landscapes as you climb to new heights.&#xD;
  &#xD;
        Acron: In this game, you take on the role of a large, ancient tree that is the sole guardian&#xD;
        of golden acorns. In this simulation, he uses an arsenal of unique abilities across seven&#xD;
        different maps to try and prevent golden acorns from being stolen. We plan to use this&#xD;
        simulation as an alternative to lower extremity strengthening exercises.&#xD;
  &#xD;
        Skiing: Start with your feet shoulder-width apart, arms at eye level and bent 90°. Then swing&#xD;
        your arms down and back while squatting. Don't squat too deep and squeeze your core. Finally,&#xD;
        swing your arms back to their original position while standing. Continue to squat and swing&#xD;
        your arms vigorously. The aim of this simulation is to provide an alternative to squatting&#xD;
        and wand exercises.&#xD;
  &#xD;
        Cycling: How to play: Stand upright, keeping your core strong and engaged, and start&#xD;
        'cycling' with your arms. There are also two ways to do circular arm movements: with the arms&#xD;
        at your sides, mostly as regular arm cycling moves, which will focus on the shoulders, chest&#xD;
        and triceps muscles, or as boxing speedbag moves, with the forearms side by side at face&#xD;
        level, which will focus on the forearms, triceps muscles and shoulder blades. The aim of this&#xD;
        simulation is to provide an alternative to balance, stick and Codman exercises.&#xD;
  &#xD;
        Questionnaires and tests to be used for evaluation Depression-Anxiety Stress Scale 21 (DASS&#xD;
        21): It is estimated that by 2020, depression, stress and anxiety-related disorders will be&#xD;
        the second most common disease in the world. The prevalence of these disorders can also have&#xD;
        a significant negative impact on countries' health expenditure, social harmony, business life&#xD;
        and individuals. This scale will be used to measure the depression burden of students.&#xD;
  &#xD;
        Motivation scale for participation in physical activity: This 16-question questionnaire&#xD;
        assesses an individual's motivation to participate in physical activity. Questions 1-6 of the&#xD;
        survey form the individual causes, 7-12 form the environmental causes and questions 13-16&#xD;
        form the dimension of irrationality. Questions 3,9,13,14,15,16 are reverse coded.&#xD;
  &#xD;
        Repetitive joint position sense test: The test is scored during arm elevation positions that&#xD;
        include 90° shoulder flexion and 90° shoulder abduction movements. For the shoulder flexion&#xD;
        assessment, the individual is asked to stand facing the millimetre paper taped to the wall.&#xD;
        The laser cursor is positioned 5 cm above the elbow joint so that wrist and elbow movements&#xD;
        do not affect the measurements. The subject is asked to flex the shoulder joint to 90°. This&#xD;
        shoulder movement is measured by the physiotherapist using a goniometer and the person is&#xD;
        asked to maintain this position for 10 seconds with eyes open. The projection of the laser&#xD;
        cursor is marked on millimetre paper. The 90° position is repeated 3 times with the eyes open&#xD;
        and the person is asked to memorise this position. It is then returned to the starting&#xD;
        position and the subject's eyes are closed. He is asked to repeat the same movement 3 times&#xD;
        and the projection of the laser cursor is marked. For the abduction movement, the subject is&#xD;
        asked to turn sideways towards the wall, with the head turned towards the wall, bringing the&#xD;
        arm to 90° abduction and the angle is measured with a goniometer. The projections of the&#xD;
        laser cursor are also marked. The starting point is assumed to be 0 and the projections of&#xD;
        the points on the x and y axes are measured during the angle repetition. The deviation is&#xD;
        calculated using the formula c=√x2+y2 (Düzgün 2011).&#xD;
  &#xD;
        Star Balance Test: The Star Balance Test, originally called the Star Excursion Balance Test,&#xD;
        is a reliable tool for measuring dynamic balance. Designed for the assessment of lower&#xD;
        extremity injuries and disorders, it is also widely used to assess dynamic balance in sport.&#xD;
        In addition, the Star Excursion Balance Test has been shown to have a high coefficient of&#xD;
        internal reliability, but its coefficients of validity have not been investigated. The test&#xD;
        is based on the ability to reach the farthest possible distance on the supporting leg with&#xD;
        the free leg in 8 different directions and is a very high quality measure of dynamic balance&#xD;
        performance in sport (Gribble 2013). Before starting the test, a dry and quiet environment&#xD;
        that is not affected by changing weather conditions should be selected for the test. This is&#xD;
        the most basic requirement for a valid and reliable test between repeated measurements.&#xD;
  &#xD;
        Required Equipment&#xD;
  &#xD;
          -  A minimum of 2×2 meters of flat, dry and suitable Ground&#xD;
  &#xD;
          -  Test manager and scoring chart&#xD;
  &#xD;
          -  Flat adhesive tape (minimum 8 meters)&#xD;
  &#xD;
          -  Ruler or Metre Application: 4 strips cut to 2 metres are placed on the floor at an angle&#xD;
             of 45 degrees. The subject should be barefoot if possible. Shoes affect the reliability&#xD;
             of the test in repeated tests. The athlete waits in the centre of the star shape (the&#xD;
             point where the lines intersect). If the right foot is chosen as the reach foot, the&#xD;
             test direction is clockwise. For the left foot, the direction is counter-clockwise. The&#xD;
             hands should be at the waist during the test and the position of the hands should not&#xD;
             change during the test. If this is not the case, the athlete places the hands on the&#xD;
             waist, repeats whichever line is left, and continues the test. The athlete reaches out&#xD;
             as far as he can with his foot and lightly touches the strip with the tip of his toe. He&#xD;
             then returns to the starting position (hands around his waist, feet in the air, on one&#xD;
             leg). Then the other line is walked and a total of 8 lines are completed in this way.&#xD;
             Each time, the examiner makes a mark with a pencil to measure the maximum point that the&#xD;
             subject can touch at a later time. After the whole process has been repeated 3 times&#xD;
             with the right foot, the left foot is switched and the process is repeated 3 times&#xD;
             (Shaffer 2013). At the end of the test, the participant records the distances reached in&#xD;
             the Cartex.&#xD;
  &#xD;
        Nelson Hand Reaction Test: The Nelson hand reaction test can be measured using the ruler&#xD;
        method. The subject is seated in a chair with the forearm and hand resting relaxed on the&#xD;
        table. The tips of the thumb and forefinger are placed 8-10 cm from the table so that they&#xD;
        are approximately parallel on the outside. The tips of the thumb and index finger should be&#xD;
        horizontal to each other. The examiner holds the tip of the ruler between the thumb and index&#xD;
        finger of the subject. The subject is instructed to look directly at the concentration zone&#xD;
        (the black area between lines 0.120 and 0.30) and to catch the ruler when it is released.&#xD;
        There are 20 trials, each starting after the 'ready' command. The result is read from the&#xD;
        line at the top of the subject's thumb after the subject has caught the ruler. The lowest 5&#xD;
        and the highest 5 trials are discarded and the average of the remaining 10 trials is recorded&#xD;
        as the result. The digits on the time scale represent thousandths of a second. The results&#xD;
        are recorded as 5/1000 seconds (Musabaşoğlu 2008).&#xD;
  &#xD;
        Mini Best Test: This test is used to evaluate the balance. The Mini Best (DDS) test has 14&#xD;
        parameters. Anticipatory postural control (standing up from sitting; toes up; standing on one&#xD;
        leg), reactive postural control (compensatory corrective stepping forward; compensatory&#xD;
        corrective stepping backward; compensatory corrective stepping sideways), sensory orientation&#xD;
        (standing position (feet together); eyes open, hard surface; standing position (feet&#xD;
        together): eyes closed, spongy surface; tilt - eyes closed), dynamic gait (change of walking&#xD;
        speed; walking with horizontal head movements; turning while walking; stepping over an&#xD;
        obstacle; double The task is evaluated with timed get up &amp; walk tests [ 3 metres walking).&#xD;
  &#xD;
        Scoring: The test consists of 14 items, each scored from 0 to 2 out of a maximum of 28. &quot;0'&#xD;
        indicates the lowest level of function and '2' indicates the highest level of function. If&#xD;
        the person requires the use of an assistive device for any item, that item is scored one&#xD;
        level lower. If the person requires physical assistance to perform the item, score that item&#xD;
        as &quot;0&quot;. For item 3 (standing on one leg) and item 6 (compensatory stepping - lateral), record&#xD;
        the score of only one side (low score). For item 3 (standing on one leg) take the best time&#xD;
        from 2 attempts (each side separately). For item 14 (time to stand up and walk with double&#xD;
        duty), the score should be reduced by one level if the person's gait slows by more than 10%&#xD;
        between double duty and non-double duty SCI.&#xD;
  &#xD;
        Measurement Evaluation and Statistical Analysis&#xD;
  &#xD;
          1. Sample size: Gpower 3.1. determined by power analysis using the programme. In the&#xD;
             analysis (α=0.05, power (1-β) = 0.80, effect size= 0.8, and at least n=26 people should&#xD;
             be included in the groups. It was set at n=30 in case of dropout.&#xD;
  &#xD;
          2. Number and names of groups in the study: Group 1: Control group Group 2: Virtual reality&#xD;
             grou&#xD;
  &#xD;
          3. Properties to be measured: Depression, anxiety, stress parameters Balance Repetitive&#xD;
             joint position sense Participation in physical activity Motivation Hand reaction&#xD;
  &#xD;
          4. Statistical analysis: The data in the study are analysed using 5 parameters&#xD;
             (skewness-curvature, Std/Mean, Q-Q plots, histogram and Shapiro-Wilk test). The&#xD;
             parameters with a score higher than 3 and a sufficient number of data are considered to&#xD;
             be normally distributed and are presented as Mean±Standard Deviation (MEAN±STD).The&#xD;
             Independent Samples T-test is used to compare two independent groups and the Related&#xD;
             Samples T-test is used to compare dependent groups. Pearson correlation is used for&#xD;
             correlation analysis of parametric data. Parameters with a score of 3 or less in the&#xD;
             normal distribution analysis are considered non-parametric, and the Mann-Whitney U test&#xD;
             is used for comparisons between two independent groups, the Wilcoxon test is used for&#xD;
             comparisons between dependent groups, and Spearman Rho's correlation analysis is used&#xD;
             for correlation analysis. In the study, α=0.05 and p&lt;α are considered significant. The&#xD;
             IBM SPSS 28.00 package programme will be used for statistical analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 5, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decrease in depression, anxiety stress parameters</measure>
      <time_frame>6 weeks</time_frame>
      <description>The specified parameters are calculated using the DASS 21 scale before and after the intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Increased hand reaction</measure>
      <time_frame>6 weeks</time_frame>
      <description>Before and after the intervention, specified parameters are measured using the Nelson Hand Reaction Test.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <condition>Stress</condition>
    <condition>Balanced</condition>
    <arm_group>
      <arm_group_label>Virtual Reality Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adequate physical activity not only reduces depression, but also prevents the neural dysfunction that can occur as a result of depression. However, the level of physical activity among young people is not sufficient. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation.&#xD;
  The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will perform individual exercise. The physical activity will be monitored with video recordings.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Virtual reality group</intervention_name>
      <description>Participants in this group will be expected to meet their physical activity levels using the Oculus Quest 2 VR Goggles platform with Racket, Climb, Acron, Skiing, Cycling games.</description>
      <arm_group_label>Virtual Reality Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering&#xD;
  &#xD;
            -  Being between 18-25 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a musculoskeletal disease&#xD;
  &#xD;
            -  Having a systemic (cardiovascular, neurological) disease&#xD;
  &#xD;
            -  Not attending the training sessions more than once&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Halil Yılmaz, PhD</last_name>
      <phone>+90 452 226 52 00</phone>
      <phone_ext>5216</phone_ext>
      <email>halilyilmaz855@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ordu University Faculty of Medicine Department of Anatomy</name>
        <address>
          <city>Ordu</city>
          <state>Black Sea</state>
          <zip>52000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Muhammet Değermenci, PhD</last_name>
        <email>mdegermenci@yahoo.com.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Bugg JM, Shah K, Villareal DT, Head D. Cognitive and neural correlates of aerobic fitness in obese older adults. Exp Aging Res. 2012;38(2):131-45. doi: 10.1080/0361073X.2012.659995.</citation>
      <PMID>22404537</PMID>
    </reference>
    <reference>
      <citation>Cole J, Costafreda SG, McGuffin P, Fu CH. Hippocampal atrophy in first episode depression: a meta-analysis of magnetic resonance imaging studies. J Affect Disord. 2011 Nov;134(1-3):483-7. doi: 10.1016/j.jad.2011.05.057. Epub 2011 Jul 13.</citation>
      <PMID>21745692</PMID>
    </reference>
    <reference>
      <citation>Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.</citation>
      <PMID>33430476</PMID>
    </reference>
    <reference>
      <citation>Cunningham G, Charbonnier C, Ladermann A, Chague S, Sonnabend DH. Shoulder Motion Analysis During Codman Pendulum Exercises. Arthrosc Sports Med Rehabil. 2020 Jun 26;2(4):e333-e339. doi: 10.1016/j.asmr.2020.04.013. eCollection 2020 Aug.</citation>
      <PMID>32875297</PMID>
    </reference>
    <reference>
      <citation>Gribble PA, Kelly SE, Refshauge KM, Hiller CE. Interrater reliability of the star excursion balance test. J Athl Train. 2013 Sep-Oct;48(5):621-6. doi: 10.4085/1062-6050-48.3.03. Epub 2013 Mar 19.</citation>
      <PMID>24067151</PMID>
    </reference>
    <reference>
      <citation>Gujral S, Aizenstein H, Reynolds CF 3rd, Butters MA, Erickson KI. Exercise effects on depression: Possible neural mechanisms. Gen Hosp Psychiatry. 2017 Nov;49:2-10. doi: 10.1016/j.genhosppsych.2017.04.012.</citation>
      <PMID>29122145</PMID>
    </reference>
    <reference>
      <citation>Kubo K, Ikebukuro T, Yata H. Effects of squat training with different depths on lower limb muscle volumes. Eur J Appl Physiol. 2019 Sep;119(9):1933-1942. doi: 10.1007/s00421-019-04181-y. Epub 2019 Jun 22.</citation>
      <PMID>31230110</PMID>
    </reference>
    <reference>
      <citation>Mu L, Cai J, Gu B, Yu L, Li C, Liu QS, Zhao L. Treadmill Exercise Prevents Decline in Spatial Learning and Memory in 3xTg-AD Mice through Enhancement of Structural Synaptic Plasticity of the Hippocampus and Prefrontal Cortex. Cells. 2022 Jan 12;11(2):244. doi: 10.3390/cells11020244.</citation>
      <PMID>35053360</PMID>
    </reference>
    <reference>
      <citation>Pizzagalli DA, Roberts AC. Prefrontal cortex and depression. Neuropsychopharmacology. 2022 Jan;47(1):225-246. doi: 10.1038/s41386-021-01101-7. Epub 2021 Aug 2. Erratum In: Neuropsychopharmacology. 2021 Aug 19;:</citation>
      <PMID>34341498</PMID>
    </reference>
    <reference>
      <citation>Rottensteiner M, Leskinen T, Niskanen E, Aaltonen S, Mutikainen S, Wikgren J, Heikkila K, Kovanen V, Kainulainen H, Kaprio J, Tarkka IM, Kujala UM. Physical activity, fitness, glucose homeostasis, and brain morphology in twins. Med Sci Sports Exerc. 2015 Mar;47(3):509-18. doi: 10.1249/MSS.0000000000000437.</citation>
      <PMID>25003773</PMID>
    </reference>
    <reference>
      <citation>Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.</citation>
      <PMID>24183777</PMID>
    </reference>
    <reference>
      <citation>Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9.</citation>
      <PMID>30003901</PMID>
    </reference>
    <reference>
      <citation>Zhang Y, Yang Y, Zhu L, Zhu Q, Jia Y, Zhang L, Peng Q, Wang J, Liu J, Fan W, Wang J. Volumetric Deficit Within the Fronto-Limbic-Striatal Circuit in First-Episode Drug Naive Patients With Major Depression Disorder. Front Psychiatry. 2021 Jan 20;11:600583. doi: 10.3389/fpsyt.2020.600583. eCollection 2020.</citation>
      <PMID>33551870</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
      <investigator_full_name>HALİL YILMAZ</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <keyword>Depression</keyword>
    <keyword>Stress</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Virtual reality glasses</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05985096
  org study id: A-2325
  nct id: NCT05985096
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute
        (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289
        people, which is 15.3% of the total population. Considering the proportion of young
        population in our country, the evaluation of physical activity level has an important place,
        while the proportion of female university students who achieved sufficient physical activity
        level according to the scoring of the International Physical Activity Questionnaire (UFAA)
        was 8.5%, while the proportion of male students was 28.1% in previous studies (Arslan 2015).
        ).
  
        We know from previous studies that achieving an adequate level of physical activity directly
        reduces the body mass index and indirectly reduces the cardiovascular risk associated with
        obesity (Swift 2018). Exercise reduces depression levels and the effects of depression.
        Although the neural mechanisms are not very clear, there are some predictions for physical
        exercise to reduce the level of depression (Gujral 2017). The hippocampus is an important
        cognitive and sensory centre, and it has been reported that hippocampal volume decreases by
        5% in depressed individuals (Cole 2011). Hippocampal volume has been reported to increase
        rapidly with exercise (Bugg 2012).
  
        The brain region most affected in major depressive disorder is the prefrontal cortex. After
        the prefrontal cortex is affected, symptoms such as negative affect and learned helplessness
        appear (Pizagalli 2021). Experimental studies in mice have shown that treadmill training
        creates new synaptic pathways in the prefrontal cortex and hippocampus (Mu 2022).
  
        Another brain region affected by depression is the corpus striatum. Loss of corpus striatum
        volume is observed in patients with major depression (Zhang 2020). The volume of the corpus
        striatum modulates when physical exercise reaches a sufficient level. (Rotttensteiner 2015).
  
        Adequate levels of physical activity not only reduce depression, but also prevent neural
        dysfunction that can occur as a result of depression. However, young people do not get enough
        exercise. Based on this fact, we believe that it is necessary to use 3D virtual reality
        applications to increase physical activity levels and exercise motivation.
  
        The aim of our study is to investigate the effect of virtual reality training on balance,
        depression, anxiety and stress parameters in healthy young people.
  Our work will last 6 weeks and is planned as exercise for 1 hour a day, 2 days a week.
  
        Group 1: The control group will do individual exercise. The monitoring of the physical
        exercises will be done with video recordings.
  
        Physical exercises Stick exercises: Shoulder stick (wand) exercises aim to perform shoulder
        range of motion exercises by supporting the sore arm with a solid arm. Use the stick to make
        forward, side, backward, outward and inward movements as shown in the picture. Count to 5 at
        the end of each movement and return to the beginning (Puendgsuwan 2008).
  
        Codman exercises: Step forward with one foot and lean forward on a stable surface such as a
        table. Release your arm using the weight: move it back and forth like a pendulum. c) Circle
        clockwise and counterclockwise (Cunningham 2020).
  
        Squat exercises: With feet open at shoulder height, the person's back is against the wall and
        positioned 10 cm in front of the wall. The rolling pin on the shoulder is grasped with the
        hands. The person faces forward. The movement is performed by bending the hip and knee joints
        without disturbing the straightness of the back and without touching the wall. Then return to
        starting position, keeping the spine straight and extending the hip and knee joints. Perform
        3 sets of 10 repetitions (Kubo 2019).
  
        Tandem walking exercise: A straight line is drawn on the floor. From the person, 10 steps are
        taken to follow this straight line with the heel of the front foot to the tip of the back
        foot. 3 sets of eyes open and 3 sets of eyes closed (Cruz 2021).
  
        Group 2: Virtual reality group. People in this group will be expected to meet their physical
        activity levels with Racket, Climb, Acron, Skiing, Cycling games using the Oculus Quest 2 VR
        goggles platform.
  
        Virtual reality games Racket: Nx is a new type of game in VR that pushes the boundaries of
        what you can do with a racket and a ball. The game takes place inside a giant glass dome, the
        walls of which are lit up with targets that you have to destroy with the cannon. But this is
        no ordinary ball. If you hit it hard, it will crash into a wall, roll over, and bulldozers
        will crush everything in its path. Use the racket's hammer beam to retreat or aim the next
        hit exactly where you want it. Targets appear in waves and the aim is to destroy them all
        before you run out of energy. But targets aren't the only thing in the arena. That's why you
        need to hit quickly and accurately. But in this game, the aim is to teach you how to control
        the ball perfectly. It is an alternative to coordination exercises.
  
        Climbing: The aim of this game is to simulate climbing. It can be used as an alternative to
        strengthening the upper limbs. From exploring mountain environments to scaling urban
        environments, the game is also designed to have the dual effect of feeling the excitement of
        climbing without ropes and experiencing the landscapes as you climb to new heights.
  
        Acron: In this game, you take on the role of a large, ancient tree that is the sole guardian
        of golden acorns. In this simulation, he uses an arsenal of unique abilities across seven
        different maps to try and prevent golden acorns from being stolen. We plan to use this
        simulation as an alternative to lower extremity strengthening exercises.
  
        Skiing: Start with your feet shoulder-width apart, arms at eye level and bent 90°. Then swing
        your arms down and back while squatting. Don't squat too deep and squeeze your core. Finally,
        swing your arms back to their original position while standing. Continue to squat and swing
        your arms vigorously. The aim of this simulation is to provide an alternative to squatting
        and wand exercises.
  
        Cycling: How to play: Stand upright, keeping your core strong and engaged, and start
        'cycling' with your arms. There are also two ways to do circular arm movements: with the arms
        at your sides, mostly as regular arm cycling moves, which will focus on the shoulders, chest
        and triceps muscles, or as boxing speedbag moves, with the forearms side by side at face
        level, which will focus on the forearms, triceps muscles and shoulder blades. The aim of this
        simulation is to provide an alternative to balance, stick and Codman exercises.
  
        Questionnaires and tests to be used for evaluation Depression-Anxiety Stress Scale 21 (DASS
        21): It is estimated that by 2020, depression, stress and anxiety-related disorders will be
        the second most common disease in the world. The prevalence of these disorders can also have
        a significant negative impact on countries' health expenditure, social harmony, business life
        and individuals. This scale will be used to measure the depression burden of students.
  
        Motivation scale for participation in physical activity: This 16-question questionnaire
        assesses an individual's motivation to participate in physical activity. Questions 1-6 of the
        survey form the individual causes, 7-12 form the environmental causes and questions 13-16
        form the dimension of irrationality. Questions 3,9,13,14,15,16 are reverse coded.
  
        Repetitive joint position sense test: The test is scored during arm elevation positions that
        include 90° shoulder flexion and 90° shoulder abduction movements. For the shoulder flexion
        assessment, the individual is asked to stand facing the millimetre paper taped to the wall.
        The laser cursor is positioned 5 cm above the elbow joint so that wrist and elbow movements
        do not affect the measurements. The subject is asked to flex the shoulder joint to 90°. This
        shoulder movement is measured by the physiotherapist using a goniometer and the person is
        asked to maintain this position for 10 seconds with eyes open. The projection of the laser
        cursor is marked on millimetre paper. The 90° position is repeated 3 times with the eyes open
        and the person is asked to memorise this position. It is then returned to the starting
        position and the subject's eyes are closed. He is asked to repeat the same movement 3 times
        and the projection of the laser cursor is marked. For the abduction movement, the subject is
        asked to turn sideways towards the wall, with the head turned towards the wall, bringing the
        arm to 90° abduction and the angle is measured with a goniometer. The projections of the
        laser cursor are also marked. The starting point is assumed to be 0 and the projections of
        the points on the x and y axes are measured during the angle repetition. The deviation is
        calculated using the formula c=√x2+y2 (Düzgün 2011).
  
        Star Balance Test: The Star Balance Test, originally called the Star Excursion Balance Test,
        is a reliable tool for measuring dynamic balance. Designed for the assessment of lower
        extremity injuries and disorders, it is also widely used to assess dynamic balance in sport.
        In addition, the Star Excursion Balance Test has been shown to have a high coefficient of
        internal reliability, but its coefficients of validity have not been investigated. The test
        is based on the ability to reach the farthest possible distance on the supporting leg with
        the free leg in 8 different directions and is a very high quality measure of dynamic balance
        performance in sport (Gribble 2013). Before starting the test, a dry and quiet environment
        that is not affected by changing weather conditions should be selected for the test. This is
        the most basic requirement for a valid and reliable test between repeated measurements.
  
        Required Equipment
  
          -  A minimum of 2×2 meters of flat, dry and suitable Ground
  
          -  Test manager and scoring chart
  
          -  Flat adhesive tape (minimum 8 meters)
  
          -  Ruler or Metre Application: 4 strips cut to 2 metres are placed on the floor at an angle
             of 45 degrees. The subject should be barefoot if possible. Shoes affect the reliability
             of the test in repeated tests. The athlete waits in the centre of the star shape (the
             point where the lines intersect). If the right foot is chosen as the reach foot, the
             test direction is clockwise. For the left foot, the direction is counter-clockwise. The
             hands should be at the waist during the test and the position of the hands should not
             change during the test. If this is not the case, the athlete places the hands on the
             waist, repeats whichever line is left, and continues the test. The athlete reaches out
             as far as he can with his foot and lightly touches the strip with the tip of his toe. He
             then returns to the starting position (hands around his waist, feet in the air, on one
             leg). Then the other line is walked and a total of 8 lines are completed in this way.
             Each time, the examiner makes a mark with a pencil to measure the maximum point that the
             subject can touch at a later time. After the whole process has been repeated 3 times
             with the right foot, the left foot is switched and the process is repeated 3 times
             (Shaffer 2013). At the end of the test, the participant records the distances reached in
             the Cartex.
  
        Nelson Hand Reaction Test: The Nelson hand reaction test can be measured using the ruler
        method. The subject is seated in a chair with the forearm and hand resting relaxed on the
        table. The tips of the thumb and forefinger are placed 8-10 cm from the table so that they
        are approximately parallel on the outside. The tips of the thumb and index finger should be
        horizontal to each other. The examiner holds the tip of the ruler between the thumb and index
        finger of the subject. The subject is instructed to look directly at the concentration zone
        (the black area between lines 0.120 and 0.30) and to catch the ruler when it is released.
        There are 20 trials, each starting after the 'ready' command. The result is read from the
        line at the top of the subject's thumb after the subject has caught the ruler. The lowest 5
        and the highest 5 trials are discarded and the average of the remaining 10 trials is recorded
        as the result. The digits on the time scale represent thousandths of a second. The results
        are recorded as 5/1000 seconds (Musabaşoğlu 2008).
  
        Mini Best Test: This test is used to evaluate the balance. The Mini Best (DDS) test has 14
        parameters. Anticipatory postural control (standing up from sitting; toes up; standing on one
        leg), reactive postural control (compensatory corrective stepping forward; compensatory
        corrective stepping backward; compensatory corrective stepping sideways), sensory orientation
        (standing position (feet together); eyes open, hard surface; standing position (feet
        together): eyes closed, spongy surface; tilt - eyes closed), dynamic gait (change of walking
        speed; walking with horizontal head movements; turning while walking; stepping over an
        obstacle; double The task is evaluated with timed get up & walk tests [ 3 metres walking).
  
        Scoring: The test consists of 14 items, each scored from 0 to 2 out of a maximum of 28. "0'
        indicates the lowest level of function and '2' indicates the highest level of function. If
        the person requires the use of an assistive device for any item, that item is scored one
        level lower. If the person requires physical assistance to perform the item, score that item
        as "0". For item 3 (standing on one leg) and item 6 (compensatory stepping - lateral), record
        the score of only one side (low score). For item 3 (standing on one leg) take the best time
        from 2 attempts (each side separately). For item 14 (time to stand up and walk with double
        duty), the score should be reduced by one level if the person's gait slows by more than 10%
        between double duty and non-double duty SCI.
  
        Measurement Evaluation and Statistical Analysis
  
          1. Sample size: Gpower 3.1. determined by power analysis using the programme. In the
             analysis (α=0.05, power (1-β) = 0.80, effect size= 0.8, and at least n=26 people should
             be included in the groups. It was set at n=30 in case of dropout.
  
          2. Number and names of groups in the study: Group 1: Control group Group 2: Virtual reality
             grou
  
          3. Properties to be measured: Depression, anxiety, stress parameters Balance Repetitive
             joint position sense Participation in physical activity Motivation Hand reaction
  
          4. Statistical analysis: The data in the study are analysed using 5 parameters
             (skewness-curvature, Std/Mean, Q-Q plots, histogram and Shapiro-Wilk test). The
             parameters with a score higher than 3 and a sufficient number of data are considered to
             be normally distributed and are presented as Mean±Standard Deviation (MEAN±STD).The
             Independent Samples T-test is used to compare two independent groups and the Related
             Samples T-test is used to compare dependent groups. Pearson correlation is used for
             correlation analysis of parametric data. Parameters with a score of 3 or less in the
             normal distribution analysis are considered non-parametric, and the Mann-Whitney U test
             is used for comparisons between two independent groups, the Wilcoxon test is used for
             comparisons between dependent groups, and Spearman Rho's correlation analysis is used
             for correlation analysis. In the study, α=0.05 and p<α are considered significant. The
             IBM SPSS 28.00 package programme will be used for statistical analysis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Decrease in depression, anxiety stress parameters
  time frame: 6 weeks
  description: The specified parameters are calculated using the DASS 21 scale before and after the intervention.
  measure: Increased hand reaction
  time frame: 6 weeks
  description: Before and after the intervention, specified parameters are measured using the Nelson Hand Reaction Test.
  arm group label: Virtual Reality Group
  arm group type: Experimental
  description: Adequate physical activity not only reduces depression, but also prevents the neural dysfunction that can occur as a result of depression. However, the level of physical activity among young people is not sufficient. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation.
  The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.
  arm group label: Control Group
  arm group type: No Intervention
  description: The control group will perform individual exercise. The physical activity will be monitored with video recordings.
  intervention type: Diagnostic Test
  intervention name: Virtual reality group
  description: Participants in this group will be expected to meet their physical activity levels using the Oculus Quest 2 VR Goggles platform with Racket, Climb, Acron, Skiing, Cycling games.
  arm group label: Virtual Reality Group
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Halil Yılmaz, PhD
  phone: +90 452 226 52 00
  phone ext: 5216
  email: halilyilmaz855@gmail.com
  facility: 
  contact: 
  country: Turkey
  citation: Bugg JM, Shah K, Villareal DT, Head D. Cognitive and neural correlates of aerobic fitness in obese older adults. Exp Aging Res. 2012;38(2):131-45. doi: 10.1080/0361073X.2012.659995.
  PMID: 22404537
  citation: Cole J, Costafreda SG, McGuffin P, Fu CH. Hippocampal atrophy in first episode depression: a meta-analysis of magnetic resonance imaging studies. J Affect Disord. 2011 Nov;134(1-3):483-7. doi: 10.1016/j.jad.2011.05.057. Epub 2011 Jul 13.
  PMID: 21745692
  citation: Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.
  PMID: 33430476
  citation: Cunningham G, Charbonnier C, Ladermann A, Chague S, Sonnabend DH. Shoulder Motion Analysis During Codman Pendulum Exercises. Arthrosc Sports Med Rehabil. 2020 Jun 26;2(4):e333-e339. doi: 10.1016/j.asmr.2020.04.013. eCollection 2020 Aug.
  PMID: 32875297
  citation: Gribble PA, Kelly SE, Refshauge KM, Hiller CE. Interrater reliability of the star excursion balance test. J Athl Train. 2013 Sep-Oct;48(5):621-6. doi: 10.4085/1062-6050-48.3.03. Epub 2013 Mar 19.
  PMID: 24067151
  citation: Gujral S, Aizenstein H, Reynolds CF 3rd, Butters MA, Erickson KI. Exercise effects on depression: Possible neural mechanisms. Gen Hosp Psychiatry. 2017 Nov;49:2-10. doi: 10.1016/j.genhosppsych.2017.04.012.
  PMID: 29122145
  citation: Kubo K, Ikebukuro T, Yata H. Effects of squat training with different depths on lower limb muscle volumes. Eur J Appl Physiol. 2019 Sep;119(9):1933-1942. doi: 10.1007/s00421-019-04181-y. Epub 2019 Jun 22.
  PMID: 31230110
  citation: Mu L, Cai J, Gu B, Yu L, Li C, Liu QS, Zhao L. Treadmill Exercise Prevents Decline in Spatial Learning and Memory in 3xTg-AD Mice through Enhancement of Structural Synaptic Plasticity of the Hippocampus and Prefrontal Cortex. Cells. 2022 Jan 12;11(2):244. doi: 10.3390/cells11020244.
  PMID: 35053360
  citation: Pizzagalli DA, Roberts AC. Prefrontal cortex and depression. Neuropsychopharmacology. 2022 Jan;47(1):225-246. doi: 10.1038/s41386-021-01101-7. Epub 2021 Aug 2. Erratum In: Neuropsychopharmacology. 2021 Aug 19;:
  PMID: 34341498
  citation: Rottensteiner M, Leskinen T, Niskanen E, Aaltonen S, Mutikainen S, Wikgren J, Heikkila K, Kovanen V, Kainulainen H, Kaprio J, Tarkka IM, Kujala UM. Physical activity, fitness, glucose homeostasis, and brain morphology in twins. Med Sci Sports Exerc. 2015 Mar;47(3):509-18. doi: 10.1249/MSS.0000000000000437.
  PMID: 25003773
  citation: Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
  PMID: 24183777
  citation: Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9.
  PMID: 30003901
  citation: Zhang Y, Yang Y, Zhu L, Zhu Q, Jia Y, Zhang L, Peng Q, Wang J, Liu J, Fan W, Wang J. Volumetric Deficit Within the Fronto-Limbic-Striatal Circuit in First-Episode Drug Naive Patients With Major Depression Disorder. Front Psychiatry. 2021 Jan 20;11:600583. doi: 10.3389/fpsyt.2020.600583. eCollection 2020.
  PMID: 33551870
  responsible party type: Principal Investigator
  investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
  investigator full name: HALİL YILMAZ
  investigator title: Assistant professor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  sharing ipd: Yes