[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05973461":3,"trial-entities:NCT05973461":109,"trial-summary:NCT05973461":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":53,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":78,"locations":81,"central_contacts":100,"overall_officials":104,"references":107,"see_also_links":108},"NCT05973461","2020-0376","Effects of Exercise and Virtual Reality on Depression","Effects of Exercise With Virtual Reality on Females and Males With or Without Depression","RECRUITING","2027-08-31","2026-05","2026-05-29","2022-05-17","The University of Texas at Arlington","OTHER",false,"This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.","Adults (males and females) above the age of 18 yrs will be recruited to determine if they have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies - Depression Scale (CES-D). They will then complete a Beck Inventory before and after the exercise. Participants will be divided into groups either having symptoms of depression or not. They will be randomized to ride on a cycle ergometer with or without using Virtual Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The ergometer will be set at resistance raising the heart rate to 65% of their age-predicted heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to determine any changes in their depressive symptoms.",[19],"Symptoms of Depression",[],"INTERVENTIONAL","SCREENING",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Exercise and virtual reality","Riding a cycle ergometer while experiencing virtual reality",[34],"Cycle Ergometer and Virtual Reality",{"type":14,"name":36,"description":37,"armGroupLabels":38},"Riding a cycle ergometer","Riding on a cycle ergometer without experiencing virtual reality",[39],"Cycle Ergometer",[41,45,49],{"measure":42,"description":43,"timeFrame":44},"Beck Depression Inventory Scale of Measurement","Assessment of symptoms of depression pre and post-intervention cycle exercise. The Beck Depression Inventory is a 21-item, multiple-choice, self-report survey that measures characteristic attitudes and symptoms of depression. The score range is 0-63. The higher the score the more severe the depression. Scores above 41 are considered \"extreme depression.\"","5 minutes",{"measure":46,"description":47,"timeFrame":48},"Spatial Working Memory (SWM)","A measure of the key aspects of working memory and storage of information over short periods of time.","8 minutes",{"measure":50,"description":51,"timeFrame":52},"Neuropsychological Outcomes: Motor Screen Tasks (MOT)","MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:","3 minutes",[54],{"measure":55,"description":56,"timeFrame":57},"Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors","This test is a general assessment of whether there are sensorimotor deficits or lack of comprehension. Outcome is measured by reaction time in milliseconds of the participant reaching out and touching the \"X\" correctly (in the middle of the X) on the tablet in response to the stimulus. The maximum score is 6000 milliseconds. The number of total correct touches and total errors in not touching correctly out of 10 are recorded. Ex: MOT mean latency = 927.9 ml +\u002F- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.","10 minutes","ALL","18 Years","65 Years",true,{"inclusion":63,"exclusion":69,"raw_text":77},[64,65,66,67,68],"Males and females over the age of 18 years","With or without symptoms of depression","Physically inactive or sedentary (less than 30 minutes per day)","Normal vision and no color blindness","No physical disorders such as walking with assistance",[70,71,72,73,74,75,76],"Below the age of 18 years or over 65 years,","Women who are pregnant","Individuals who have been diagnosed with mental disorders","Individuals with leg injuries","Individuals with cardiac problems","Individuals with a history of asthma","Individuals with a body mass index over 30.","Inclusion Criteria:\n\n* Males and females over the age of 18 years\n* With or without symptoms of depression\n* Physically inactive or sedentary (less than 30 minutes per day)\n* Normal vision and no color blindness\n* No physical disorders such as walking with assistance\n\nExclusion Criteria:\n\n* Below the age of 18 years or over 65 years,\n* Women who are pregnant\n* Individuals who have been diagnosed with mental disorders\n* Individuals with leg injuries\n* Individuals with cardiac problems\n* Individuals with a history of asthma\n* Individuals with a body mass index over 30.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":97},"UTArlington","Arlington","Texas","76019","United States",[89,94],{"name":90,"role":91,"phone":92,"email":93},"Judy R Wilson, Ph.D.","CONTACT","817-272-3128","jrwilson@exchange.uta.edu",{"name":95,"role":91,"email":96},"Xiangli Gu, Ph.D.","xiangli.gu@uta.edu",{"lat":98,"lon":99},32.73569,-97.10807,[101,103],{"name":102,"role":91,"phone":92,"email":93},"Judy R Wilson, PH.D.",{"name":95,"role":91,"email":96},[105],{"name":90,"affiliation":83,"role":106},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Depression",[],{"nct_id":4,"found":61,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study, meaning participants will receive a specific intervention. Participants will be divided into groups and randomly assigned to either ride a cycle ergometer with or without virtual reality.","completed","Exercise and Virtual Reality for Depression Symptoms","This study is looking at how exercise, specifically riding a stationary bike (cycle ergometer), combined with virtual reality (VR) might affect symptoms of depression. Researchers want to see if riding a bike while experiencing VR, like viewing neighborhoods or parks, can improve mood. You might be able to join if you are between 18 and 65 years old, with or without symptoms of depression, and are generally inactive. You should also have normal vision and no physical conditions that make walking difficult. The study will measure changes in your depression symptoms using a questionnaire called the Beck Depression Inventory Scale. The study aims to enroll 200 participants, but its current recruitment status is unclear.","Your depression symptoms will be measured immediately after the exercise (at 5 minutes), and your spatial working memory and motor skills will be measured shortly after (at 8 and 3 minutes, respectively).",114,"You would complete a depression questionnaire before and after exercising. You would ride a cycle ergometer for 20 minutes at a specific heart rate.","Not stated in the trial record.",[],"v2"]