Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-06 @ 9:58 AM
Study NCT ID:
NCT06587932
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2024-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Gym Exercises on Risk of Fall, Balance and Quality of Life in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'risk of fall', 'timeFrame': '6 months', 'description': 'Modified Arabic version of Activities specific balance confidence scale to assess the risk of fall.'}, {'measure': 'Static balance', 'timeFrame': '6 months', 'description': 'Berg scale for static balance assessment'}, {'measure': 'Dynamic balance', 'timeFrame': '6 months', 'description': 'Balance check 636 device'}, {'measure': 'Health related quality of life', 'timeFrame': '6 months', 'description': 'Arabic version of WHO quality of life quationare bref to assess health related quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese Subjects']}, 'descriptionModule': {'briefSummary': 'This study will be done to answer the following question:\n\nDo brain gym exercises have an effect on risk of fall, static balance, dynamic balance and risk of fall and quality of life in obese subjects?', 'detailedDescription': 'Obesity has now become a severe and inescapable worry for people of all generations. Obesity is associated with an excessive or inappropriate fat build-up that poses a health concern. A BMI of 25 or above is considered to be overweight, while a BMI of 30 is classified as obese. In 2017, nearly 4 million individuals died as a direct result of being overweight and obese, according to the global burden of sickness report. Postural equilibrium is required for us to function normally in our daily lives. The ability to manage the center of mass inside the base of support, which serves to maintain the body in balance, is characterized as equilibrium. Balance is described as the process of maintaining the body center of gravity within its support base, which necessitates regular modifications given by muscle activity and joint alignment . 1. Thirty-two obese subjects from both gender with age ranging from 18-50 years old . And BMI ≥ 30 kg/m2. They will be selected from faculty of physical therapy Kafr Elshikh university Group A (exprimental group): 16 subjects received brain gym exercises for 15-30 minutes per day, three times a week, for eight consecutive weeks . And traditional treatment in form of balance training included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks Group B (control group): 16 subjects will receive traditional treatment in form of balance training included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:1- Obese subjects from both gender age range from 18-50 years old (Cruz-Gomez et al., 2021) 2- BMI ≥ 30 kg/m2\n\n\\-\n\nExclusion Criteria:neurological conditions affect the balance as:\n\n* Alzheimer's disease\n* Parkinson's disease\n* Head injuries\n* Peripheral neuropathy\n* Headaches or migraines 2. lower limb injuries 3. Postural hypotension 4. Motion sickness 5. Diabetes mellitus 6. Pregnancy 7. Rheumatoid arthritis 8. osteoporosis"}, 'identificationModule': {'nctId': 'NCT06587932', 'briefTitle': 'Brain Gym Exercises on Risk of Fall, Balance and Quality of Life in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Brain Gym Exercises on Risk of Fall, Balance and Quality of Life in Obese Subjects', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (exprimental group)', 'description': '16 subjects received brain gym exercises for 15-30 minutes per day, three times a week, for eight consecutive weeks . And traditional treatment in form of balance exercise included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks.', 'interventionNames': ['Other: brain gym exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (balance exercise):', 'description': '16 subjects will receive traditional treatment in form of balance exercise included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks.', 'interventionNames': ['Other: Traditional treatments']}], 'interventions': [{'name': 'brain gym exercises', 'type': 'OTHER', 'description': 'It is comprised very easy body movements which have been designed to coax the two hemispheres of the brain.', 'armGroupLabels': ['Group A (exprimental group)']}, {'name': 'Traditional treatments', 'type': 'OTHER', 'description': 'traditional treatment in form of balance training included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other', 'armGroupLabels': ['Group B (balance exercise):']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Maher A Elkeblawy, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'professor Cairo university'}, {'name': 'Yasser Ramzy Lasheen, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor Cairo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EFFECT OF BRAIN GYM EXERCISES ON RISK OF FALL, BALANCE AND QUALITY OF LIFE IN OBESE SUBJECTS', 'investigatorFullName': 'Aya AbdElhady Ahmed Ali Elerian', 'investigatorAffiliation': 'Cairo University'}}}}