Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 1:58 AM
Study NCT ID:
NCT07092228
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Exercise Capacity in Teenage Females Using Virtual Reality and Plyometric Workout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'using computer software'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'waist circumference in centimeter', 'timeFrame': '12 weeks', 'description': 'An objective outcome measure, measured by a tap measurement before and after treatment protocol'}, {'measure': 'waist-hip ratio in centimeter', 'timeFrame': '12 weeks', 'description': 'objective measure objective outcome measure, measured by a tap measurement before and after treatment protocol'}, {'measure': 'Body mass index (BMI) in kg/m²', 'timeFrame': '12 weeks', 'description': "objective outcome measure, s calculated by dividing an individual's weight in kilograms by the square of their height in meters. For children and adolescents, BMI values are categorized to assess weight status (underweight, healthy weight, overweight, obese"}, {'measure': 'pulmonary function tests by using electronic spirometry', 'timeFrame': '12 weeks', 'description': "An objective outcome measure like Forced Expiratory Volume in one second. It's a key measurement in spirometry tests, helping to assess lung function and diagnose conditions like asthma"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'plyometric exercises', 'abdominal obesity', 'exercise capacity'], 'conditions': ['Abdominal Obesity']}, 'descriptionModule': {'briefSummary': 'to evaluate the efficacy of virtual reality combined with plyometric workout on abdominal obesity in adolescent females', 'detailedDescription': 'A total sample size of 100 adolescent females will be assigned to the study and will be divided randomly into two study groups, Study Group A and Study Group B, with 50 subjects in each group. Before the start of the protocol (first session) specific parameters will be taken from all assigned adolescent females in the two groups like waist circumference, waist-hip ratio, Body Mass Index, and some pulmonary function tests in the form of inspiratory reserve volume, Expiratory reserve volume, tidal volume, Inspiratory capacity, and vital capacity. Then, study group A underwent an immersive virtual reality technique in addition to plyometric exercise. Study group B was assigned to a treadmill aerobic workout for 10 minutes in addition to plyometric exercises. All mentioned parameters will be measured again after three months of the treatment program'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'genderBased': True, 'genderDescription': 'not required', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index more than or equal to 30 Kg/cm2\n* waist circumference more than 80 cm\n* medical history of polycystic ovarian syndrome\n* Age from 13 to 18 years\n\nExclusion Criteria:\n\n* uncontrolled hypertension\n* Rheumatoid arthritis\n* Any respiratory diseases like Asthma and respiratory infections\n* Osteoprosis'}, 'identificationModule': {'nctId': 'NCT07092228', 'acronym': 'VR', 'briefTitle': 'Evaluation of Exercise Capacity in Teenage Females Using Virtual Reality and Plyometric Workout', 'organization': {'class': 'OTHER', 'fullName': 'New Ismailia National University'}, 'officialTitle': 'Evaluation of Exercise Capacity in Teenage Females With Abdominal Obesity Using Virtual Reality and Plyometric Workout: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB # 3/6/2024- 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality and plyometrics', 'description': 'using immersed virtual reality combined with plyometric exercises for the lower extremity, in addition to abdominal exercises', 'interventionNames': ['Device: virtual reality and plyometric workout']}, {'type': 'EXPERIMENTAL', 'label': 'Treadmill and plyometric', 'description': 'using a treadmill aerobic training combined with plyometric exercises for the lower extremity, in addition to abdominal exercises', 'interventionNames': ['Device: virtual reality and plyometric workout']}], 'interventions': [{'name': 'virtual reality and plyometric workout', 'type': 'DEVICE', 'otherNames': ['treadmill aerobic training and plyometric workout'], 'description': 'to evaluate exercise capacity in teenage females with abdominal obesity using virtual reality and plyometric workouts', 'armGroupLabels': ['Treadmill and plyometric', 'Virtual Reality and plyometrics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8332601', 'city': 'Ismailia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed AM Abo El Ros, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.aboelros@pt.ninu.edu.eg', 'phone': '01206530584'}, {'role': 'CONTACT', 'email': 'mohamed.aboelros@pt.ninu.edu.eg', 'phoneExt': 'Abo El Ros'}, {'name': 'Mohamed AM Abo El Ros, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mohamed', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'centralContacts': [{'name': 'Mohamed AM Abo El Ros', 'role': 'CONTACT', 'email': 'mohamed.aboelros@pt.ninu.edu.eg', 'phone': '01206530584'}, {'name': 'Krols Isak', 'role': 'CONTACT', 'email': '3530@zuj.edu.jo', 'phone': '0781524278'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Ismailia National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatric Physical Therapy', 'investigatorFullName': 'Mohamed Abdel Moeim Abo EL Ros', 'investigatorAffiliation': 'New Ismailia National University'}}}}