Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT05973461
Status:
SUSPENDED
Last Update Posted:
2025-07-17
First Post:
2023-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise and Virtual Reality on Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'males and females, with and without symptoms of depression'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'analyzing data', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory Scale of Measurement', 'timeFrame': '5 minutes', 'description': '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."'}, {'measure': 'Spatial Working Memory (SWM)', 'timeFrame': '8 minutes', 'description': 'A measure of the key aspects of working memory and storage of information over short periods of time.'}, {'measure': 'Neuropsychological Outcomes: Motor Screen Tasks (MOT)', 'timeFrame': '3 minutes', 'description': 'MOT provides a general indication that psychomotor function is intact enough to proceed with more sophisticated cognitive testing:'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors', 'timeFrame': '10 minutes', 'description': '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 +/- 131.43 ms; MOT Total Correct = 10; MOT Total Errors = 0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Symptoms of Depression']}, 'descriptionModule': {'briefSummary': 'This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT05973461', 'briefTitle': 'Effects of Exercise and Virtual Reality on Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Arlington'}, 'officialTitle': 'Effects of Exercise With Virtual Reality on Females and Males With or Without Depression', 'orgStudyIdInfo': {'id': '2020-0376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycle Ergometer and Virtual Reality', 'description': '30 min ride on cycle ergometer while viewing neighborhood scenes using virtual reality', 'interventionNames': ['Device: Exercise and virtual reality']}, {'type': 'EXPERIMENTAL', 'label': 'Cycle Ergometer', 'description': '30 min ride on cycle ergometer', 'interventionNames': ['Other: Riding a cycle ergometer']}], 'interventions': [{'name': 'Exercise and virtual reality', 'type': 'DEVICE', 'description': 'Riding a cycle ergometer while experiencing virtual reality', 'armGroupLabels': ['Cycle Ergometer and Virtual Reality']}, {'name': 'Riding a cycle ergometer', 'type': 'OTHER', 'description': 'Riding on a cycle ergometer without experiencing virtual reality', 'armGroupLabels': ['Cycle Ergometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76019', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'UTArlington', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}], 'overallOfficials': [{'name': 'Judy R Wilson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTArlington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Arlington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Judy Wilson', 'investigatorAffiliation': 'The University of Texas at Arlington'}}}}