[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551770":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":55,"studyPopulation":45,"armGroups":56,"interventions":68,"overallOfficials":78,"centralContacts":82,"locations":87,"responsibleParty":103,"collaborators":45,"id":106,"slug":45,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":45,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":45,"enrollmentInfo":115,"targetDuration":45,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":89,"whyStopped":45,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Augusta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"VO2peak","The highest level of oxygen uptake averaged over a 20-second period.","Assessed during the exercise test for each condition.",{"measure":14,"description":15,"timeFrame":12},"Ventilatory threshold","The work load (in Watts) during the maximal cardiorespiratory exercise test at which breakpoints are identified between metabolic measures associated with the ventilatory threshold (CO2 production and O2 utilization; ventilatory equivalent for O2 and O2 utilization; and excess CO2 production).",[17,20,23,27,30,33,36,39,42],{"measure":18,"description":19,"timeFrame":12},"Peak power","The work load (in Watts) of the highest exercise test stage that was completed",{"measure":21,"description":22,"timeFrame":12},"Total test time","The duration of the test (in minutes), not including the warm-up.",{"measure":24,"description":25,"timeFrame":26},"RPE","Rating of Perceived Exertion measured from 0 (no perceived exertion) to 10 (maximal perceived exertion).","Assessed throughout the exercise test for each condition (at the end of the warm-up and end of every even-numbered stage)..",{"measure":28,"description":29,"timeFrame":26},"Affective Valence","Affective valence measured from -5 (feeling very bad) to +5 (feeling very good).",{"measure":31,"description":32,"timeFrame":12},"%VO2peak at ventilatory threshold","The percentage of VO2peak at which the ventilatory threshold was reached.",{"measure":34,"description":35,"timeFrame":12},"Heart rate at ventilatory threshold","The heart rate corresponding to the time that the ventilatory threshold was reached.",{"measure":37,"description":38,"timeFrame":12},"Heart rate at VO2peak","The heart rate (in beats per minute) at which VO2peak was reached.",{"measure":40,"description":41,"timeFrame":12},"Respiratory Exchange Ratio (RER) at VO2peak","The proportion of carbon dioxide production to oxygen consumption when VO2peak was reached.",{"measure":43,"description":44,"timeFrame":12},"Respiratory Exchange Ratio (RER) at ventilatory threshold","The proportion of carbon dioxide production to oxygen consumption when the ventilatory threshold was reached.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":6,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","CROSSOVER","This study will use a repeated-measures crossover model in which each participant completes the two conditions of the maximal exercise test (Control and Virtual Reality) in a randomized, counterbalanced order.",{"masking":51,"maskingDescription":52,"whoMasked":53},"SINGLE","It is not possible to mask the participant or data collection personnel from the conditions because the Virtual Reality condition requires that the headset be worn. Metabolic data and resulting outcomes (i.e. VO2peak value) will be analyzed by independent research assistants who will be blinded to the condition under which the data were gathered.",[54],"OUTCOMES_ASSESSOR","Virtual reality imparts a dissociative effect on users during exercise, such that the physical activity task is experienced as more enjoyable and pleasant, requires less exertion, and requires less physiological function for a given submaximal work rate.\n\nThis array of positive effects may be particularly advantageous during a maximal aerobic exercise test, mainly because participant motivation and negative psychological state often lead to premature test termination. Ameliorating the unpleasantness of this type of exercise test with the use of virtual reality technology may prolong effort expenditure during the test and result in superior performance compared to a control condition.\n\nAdditionally, improving physiological function at submaximal work rates may lead to alterations in other important testing outcomes, particularly the ventilatory threshold. The ventilatory threshold is used as a reference point for prescribing exercise intensity. An intervention that modifies this value would have repercussions for physical fitness practitioners who prescribe exercise intensity relative to the ventilatory threshold.\n\nThe general purpose of this study is to determine the effect of virtual reality on maximal aerobic exercise test performance in healthy adults. The specific questions it aims to answer are:\n\n* Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,\n* Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?\n\nSecondary questions this study aims to answer include:\n\nDoes using a virtual reality program during a maximal aerobic exercise test lead to differences in\n\n* exercise test time?\n* maximal heart rate during the exercise test?\n* maximal respiratory exchange ratio (RER) during the exercise test?\n* heart rate (HR) at the ventilatory threshold?\n* RER at the ventilatory threshold?\n* psychological response \\[rating of perceived exertion (RPE) and affective valence\\] throughout the exercise test?\n\nTo address these aims, participants will complete the same maximal aerobic exercise test on a cycler ergometer under normal laboratory conditions (Control) and when viewing an immersive virtual reality video (VR). The two tests will be completed in a randomized and counterbalanced order to account for learning or familiarity effects, and will be separated by 1 week to account for the effects of testing fatigue.\n\nRespiratory data, HR, RPE, and affective valence were collected during the exercise tests to address the aims of the study.",[57,64],{"label":58,"type":59,"description":60,"interventionNames":61},"Control condition completed first","EXPERIMENTAL","In this arm, the Control condition (traditional maximal cardiorespiratory exercise test) will be completed first, and the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed second.",[62,63],"Behavioral: Virtual Reality condition","Behavioral: Control condition",{"label":65,"type":59,"description":66,"interventionNames":67},"Virtual Reality condition completed first","In this arm, the Virtual Reality condition (traditional maximal cardiorespiratory exercise test with the addition of virtual reality video) will be completed first, and the Control condition (traditional maximal cardiorespiratory exercise test) will be completed second.",[62,63],[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":45},"BEHAVIORAL","Virtual Reality condition","Participants will watch a video on a virtual reality headset during the completion of the maximal cardiorespiratory exercise test.",[58,65],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":45},"Control condition","Participants will complete the maximal cardiorespiratory exercise test under control conditions without video, music, or other distractions.",[58,65],[79],{"name":80,"affiliation":5,"role":81},"Andrew R Moore, PhD","PRINCIPAL_INVESTIGATOR",[83],{"name":80,"role":84,"phone":85,"phoneExt":45,"email":86},"CONTACT","650-477-7746","andmoore@augusta.edu",[88],{"facility":5,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Augusta","Georgia","30909","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-81.97484,33.47097,{"lat":99,"lon":98},[102],{"name":80,"role":84,"phone":85,"phoneExt":45,"email":86},{"type":81,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Andrew Moore","Assistant Professor","100551770",false,"NCT06464406","Virtual Reality During Exercise Testing","Effects of Virtual Reality on Cardiorespiratory Fitness Test Results","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Answering \"YES\" to one or more items on the Physical Activity Readiness Questionnaire (PAR-Q).\n* Women who are pregnant at the time of participation according to a pregnancy test.",true,"ALL","18 Years",{"count":116,"type":117},24,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this clinical trial is to explore the effects of virtual reality use on maximal aerobic exercise test performance (aerobic capacity) in healthy adults. The main questions it aims to answer are:\n\n* Does using a virtual reality program during a maximal aerobic exercise test lead to differences in VO2peak (maximal aerobic capacity)? and,\n* Does using a virtual reality program during a maximal aerobic exercise test lead to differences in work rate at the ventilatory threshold?\n\nParticipants will complete a maximal aerobic exercise test two times (separated by 1 week of recovery) under the following conditions:\n\n* normal testing conditions in a lab\n* while viewing a virtual reality video\n\nResearchers will compare the test results of both conditions to see if the use of a virtual reality program alters VO2peak or the ventilatory threshold.",[123],"Virtual Reality",[125,126,127,128],"virtual reality","cardiorespiratory fitness","anaerobic threshold","bicycle ergometer test","2024-06-19",{"date":131,"type":132},"2024-06-21","ACTUAL",{"date":134,"type":132},"2024-06-07",{"date":136,"type":117},"2024-10-07",{"name":5,"class":6},1]