Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT04932694
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2021-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-06-12', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core endurance tests', 'timeFrame': '2 months', 'description': 'These tests consisted of four positions and calculated the time spent during the test.'}, {'measure': 'Flexor extensor isokinetic torque', 'timeFrame': '2 months', 'description': 'These tests consist of flexor and extensor isokinetic torque assessment.'}], 'secondaryOutcomes': [{'measure': 'Balance assessment', 'timeFrame': '2 months', 'description': 'assess the body balance using balance biodex system'}, {'measure': '6 min walking test', 'timeFrame': '2 months', 'description': 'Assess aerobic capacity and endurance by measuring the distance covered in 6 minutes'}, {'measure': 'Function Assessment', 'timeFrame': '2 months', 'description': 'Assess function disability using Oswestry disability index questionnaire.'}, {'measure': 'Trunk sense of position', 'timeFrame': '2 months', 'description': 'Assess position sense of the trunk'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Core training', 'Stabilization exercises'], 'conditions': ['Bariatric Surgery', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.', 'detailedDescription': 'This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female\n* age ranged from 18-25 years old,\n* at least 6 months after BS\n\nExclusion Criteria:\n\n* Patients with nerve root compression\n* spine disorders\n* spinal fracture\n* previous spinal surgery\n* pregnancy\n* lower limb injury\n* Any contraindication to the exercise therapy'}, 'identificationModule': {'nctId': 'NCT04932694', 'briefTitle': 'Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Bariatric Surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Core stabilization exercises will be conducted for 8 weeks, 3 sessions per day at home, and exercises will be supervised remotly.', 'interventionNames': ['Other: Core stabilization training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No exercise will be given to the participants in the control group'}], 'interventions': [{'name': 'Core stabilization training', 'type': 'OTHER', 'otherNames': ['Exercises'], 'description': 'Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Giza', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'Olfat Ibrahim Ali', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'zip': '12611', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Olfat Ibrahim Ali', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Olfat I Ali, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Batterjee Medical College', 'class': 'OTHER'}, {'name': 'Taif University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Olfat Ibrahim Ali', 'investigatorAffiliation': 'Cairo University'}}}}