Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT03753295
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2018-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of BMI on Hand Grip Force in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006230', 'term': 'Hand Injuries'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2018-11-23', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand Grip Force of the Right Dominant Hand in The Three Groups', 'timeFrame': '10 minutes', 'description': 'Hand Grip strength will be measured in three groups and comparison between them will be made'}, {'measure': 'Comparison of Hand Grip Force between Both Arms in three Groups', 'timeFrame': '20 minutes', 'description': 'Measurement of both right dominant hand and left hand will be measured in the three groups and compared with each other.'}], 'secondaryOutcomes': [{'measure': 'the effect of gender on the hand grip', 'timeFrame': '10 minutes', 'description': 'measurement of hand grip force of the right dominant hand will be taken for both male and females in the three subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMI, Hand Grip, Healthy Adults'], 'conditions': ['Motor Activity', 'Overweight and Obesity', 'Hand Injuries']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate the effect of BMI on hand grip force in healthy subjects. The participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from College of Applied Medical Sciences, Jazan University.', 'detailedDescription': 'Subjects will be categorized according to BMI into three groups:\n\nGroup I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI\\<25 kg/m2) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2).\n\nGroup III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI\\>30 kg/m2).\n\nBaseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) will be used to measure the hand grip strength and pinch strength'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '90 healthy male and female students with age 19 to 25 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects would not have any diseases of the central nervous system.\n2. Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.\n3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .\n\nExclusion Criteria:\n\n1. Sign of foot pain, reduced tactile and thermal foot sensibility.\n2. Peripheral neuropathy.\n3. A history of previous back or abdominal surgery/injury\n4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .\n5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.\n6. Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab \\& Kachanathu, 2016).'}, 'identificationModule': {'nctId': 'NCT03753295', 'briefTitle': 'The Effect of BMI on Hand Grip Force in Healthy Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'The Effect of BMI on Hand Grip Force in Healthy Adults', 'orgStudyIdInfo': {'id': '27704112500'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I (normal subjects)', 'description': '30 individuals (15 male, and 15 female students) with (BMI\\<25 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.', 'interventionNames': ['Diagnostic Test: Hand Grip Force']}, {'label': 'Group II (overweight subjects)', 'description': '30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.', 'interventionNames': ['Diagnostic Test: Hand Grip Force']}, {'label': 'Group III (obese subjects)', 'description': '30 individuals (15 male, and 15 female students) (BMI\\>30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.', 'interventionNames': ['Diagnostic Test: Hand Grip Force']}], 'interventions': [{'name': 'Hand Grip Force', 'type': 'DIAGNOSTIC_TEST', 'description': 'For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.\n\nThe elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.\n\nThe test will be performed twice, and the higher value between the two measurements will be selected.\n\nThe subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress', 'armGroupLabels': ['Group I (normal subjects)', 'Group II (overweight subjects)', 'Group III (obese subjects)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Riyadh', 'state': 'Jazan Region', 'country': 'Saudi Arabia', 'facility': 'Jazan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wafaa Mahmoud Amin', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Wafaa Mahmoud Amin', 'investigatorAffiliation': 'University of Jazan'}}}}