Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 5:03 AM
Study NCT ID:
NCT05563805
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Virtual Reality Adventure Training Exergaming
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two group (intervention and control) randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, Week 6-8, Week 12', 'description': 'Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).'}], 'secondaryOutcomes': [{'measure': 'Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, post-training, Week 12', 'description': 'Anxiety will be measured using the Beck Anxiety Inventory (BAI).'}, {'measure': 'Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, post-training, Week 12', 'description': 'Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5).'}, {'measure': 'Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, post-training, Week 12', 'description': "Cognitive Function will be measured via the Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess the participants' executive function and working memory via multitasking test and spatial working memory tests."}, {'measure': 'Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, Week 6-8, Week 24', 'description': 'Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey.'}, {'measure': 'BMI change from baseline to week 6-8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, post-training, Week 12', 'description': "Participants' height and weight will be measured to calculate their BMI."}, {'measure': 'Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, Week 8, Week 24', 'description': 'Physical Activity and Sedentary Behavior will be measured objectively using the ActiGraph GT9X accelerometers'}, {'measure': 'Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)', 'timeFrame': 'Baseline, post-training, Week 12', 'description': 'Heart Rate Variability will be measured using ECG (electrocardiogram)-derived heart rate variability from a Polar H10 Heart Rate Monitor Chest strap and HRV-monitoring app.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Physical Activity', 'Sedentary Behavior', 'Depression', 'Cognitive Function', 'Post Traumatic Stress Disorder', 'Quality of Life', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.', 'detailedDescription': 'The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. The project addresses two specific aims:\n\nAim 1. To examine the effects of an 8-week V-RATE intervention on physical health (i.e., BMI, physical activity, sedentary behavior) among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group would exhibit more improvement in the physical health indicators after the intervention compared to individuals in the control group. We further hypothesize gains would be maintained or enhanced at 1-month follow-up measure.\n\nAim 2. To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health-related quality of life), among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group will exhibit more improvement in the mental health indicators after the intervention compared to individuals in the control group. We further hypothesize gains maintained or enhanced at 1-month follow-up measure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female sex at birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are between the ages of 18 and 45\n2. Identify as a U.S. military veteran\n\n4\\. Normal vision (no colorblindness)\n\nExclusion Criteria:\n\n1. Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter)\n2. Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury\n3. Self-reported pregnancy or suspicion of pregnancy\n4. Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism)\n5. Self-reported color blindness\n6. Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure)\n7. Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.'}, 'identificationModule': {'nctId': 'NCT05563805', 'acronym': 'V-RATE', 'briefTitle': 'Exploring Virtual Reality Adventure Training Exergaming', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Arlington'}, 'officialTitle': "Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes", 'orgStudyIdInfo': {'id': 'UTexasArlington'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'intervention participants will engage in a 30-minutes VR adventure games on a non-mobilized treadmill (5-min warm-up, 20-minutes treadmill, and 5-min cool-down) for a total of 6 sessions over 6-8 weeks. Participants in the V-RATE group will be instructed to self-pace walking/running on the treadmill while they are fully immersed in the VR games for two 10-minute bouts with a complete rest interval (heart rate reduces to normal range). Participants will complete measures at baseline, post-training, and one-month follow-up.', 'interventionNames': ['Device: Virtual Reality-based physical activity intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control participants will not receive the intervention. Participants will complete measures at baseline, post-training, and one-month follow-up.'}], 'interventions': [{'name': 'Virtual Reality-based physical activity intervention', 'type': 'DEVICE', 'description': 'The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 sessions. The V-RATE program will be focused on creating a safe and immersive environment supportive of physical activity. The treadmill enables an individual can walk and run at self-paced speed, moving in 360-degrees (i.e., forwards, sideways, and backwards) without risk of falling. The core feature of the self-paced treadmill is a concave walking platform with an adjustable waist hardness that enables a safe, smooth, natural gait while adults with elevated BMI engage in an immersive walking and running motion. During the V-RATE intervention, participants will self-pace their locomotor action (walking/running/bending/ jumping) while they wear the VR headset and experience immersive VR adventure games using the Omniverse VR system.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76019', 'city': 'Arlington', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donna L Schuman, PhD', 'role': 'CONTACT', 'email': 'donna.schuman@uta.edu', 'phone': '817-272-3181'}, {'name': 'Xiangli L Gu, PhD', 'role': 'CONTACT', 'email': 'donna.schuman@uta.edu', 'phone': '817-818-2106'}], 'facility': 'University of Texas at Arlington', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}], 'centralContacts': [{'name': 'Donna L Schuman, PhD', 'role': 'CONTACT', 'email': 'donna.schuman@uta.edu', 'phone': '18172723181'}, {'name': 'Xiangli Gu, PhD', 'role': 'CONTACT', 'email': 'xiangli.gu@uta.edu', 'phone': '817-818-2106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Arlington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Donna L. Schuman', 'investigatorAffiliation': 'The University of Texas at Arlington'}}}}