Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-26 @ 12:39 PM
Study NCT ID:
NCT06645418
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2024-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Hand Grip Strength and Functional Fitness in Diabetic Patient in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-10-12', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relative Hand grip strength', 'timeFrame': 'Baseline', 'description': 'the sum of the handgrip strength of both hands divided by body mass index (BMI)'}, {'measure': 'The 30-Second Chair Test', 'timeFrame': 'Baseline', 'description': 'The 30-Second Chair Test is a standing exercise where participants sit in a folding chair without arms, with their feet shoulder-width apart and arms crossed. The test requires the participant to perform full stands within 30 seconds, with the goal of completing the task without using their arms.'}, {'measure': '8-feet Up-and-Go test', 'timeFrame': 'Baseline', 'description': 'Place a chair and marker 8 feet apart, clear the path, and start seated. Start timing, then quickly stand, walk, and walk around a cone, returning to the chair. Stop timing as needed. Perform two trials.'}, {'measure': '2 min walk test', 'timeFrame': 'Baseline', 'description': 'For two minutes, the person is urged to walk as quickly as they can while remaining safe and independent, and the distance is recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type II Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.', 'detailedDescription': 'To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes type II\n* Ability to walk independently\n* The cognitive and mental capacity to understand and perform tests\n\nExclusion Criteria:\n\n* Musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping'}, 'identificationModule': {'nctId': 'NCT06645418', 'briefTitle': 'Relative Hand Grip Strength and Functional Fitness in Diabetic Patient in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Relative Hand Grip Strength and Functional Fitness Among Elderly Patients with Type II Diabetes in Egypt: a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'Hand Grip'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetic group', 'description': '100 randomly selected older adults with DM II, of both sexes who are attending endocrine outpatient clinics in governmental hospitals.', 'interventionNames': ['Diagnostic Test: relative Hand grip strength', 'Diagnostic Test: senior fitness test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non diabetic group', 'description': '100 older adults non diabetic, of both sexes who are attending endocrine outpatient clinics in governmental hospitals.', 'interventionNames': ['Diagnostic Test: relative Hand grip strength', 'Diagnostic Test: senior fitness test']}], 'interventions': [{'name': 'relative Hand grip strength', 'type': 'DIAGNOSTIC_TEST', 'description': "To perform this study the relative handgrip strength (rHGS) index was used. The rHGSi is defined as the sum of the handgrip strength of both hands divided by body mass index (BMI), and it is considered a better prognostic tool than handgrip strength. rHGS was measured by Jamar hand dynamometer. The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).", 'armGroupLabels': ['Diabetic group', 'non diabetic group']}, {'name': 'senior fitness test', 'type': 'DIAGNOSTIC_TEST', 'description': "The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).", 'armGroupLabels': ['Diabetic group', 'non diabetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31611', 'city': 'Cairo', 'state': 'Elgharbia', 'country': 'Egypt', 'facility': 'Kz hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kz Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed Yo Elhamrawy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National institute for Gerontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical therapy', 'investigatorFullName': 'Mohammed Youssef Elhamrawy', 'investigatorAffiliation': 'Beni-Suef University'}}}}