Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT06223802
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2024-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biodex Training in Hemodialysis Females With Osteopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006461', 'term': 'Hemolysis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-03-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density of femur bone', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it will be measured by DEXA'}], 'secondaryOutcomes': [{'measure': 'overall stability index', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it a parameter indicates the good balance of patients'}, {'measure': 'Antero posterior stability index', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it a parameter indicates the good balance of patients'}, {'measure': 'Mediolateral stability index', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it a parameter indicates the good balance of patients'}, {'measure': 'six minute walk test', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it a parameter asses funntional capacity'}, {'measure': 'Short physical performance battery', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'total score or points will be assessed from this physical performance test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemolysis']}, 'descriptionModule': {'briefSummary': 'imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance', 'detailedDescription': '58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteopneia women\n* hemodialysis women\n\nExclusion Criteria:\n\n* pregnancy\n* autoimmune disorders\n* lower limb orthopedic problems\n* psychological manifestaion'}, 'identificationModule': {'nctId': 'NCT06223802', 'briefTitle': 'Biodex Training in Hemodialysis Females With Osteopenia', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Balance Response to Biodex Training in Hemodialysis Females With Osteopenia', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trained group', 'description': 'women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks', 'interventionNames': ['Behavioral: biodex training']}, {'type': 'NO_INTERVENTION', 'label': 'non trained group', 'description': 'this group will serve as a control group that will receive no intervention'}], 'interventions': [{'name': 'biodex training', 'type': 'BEHAVIORAL', 'description': 'women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks', 'armGroupLabels': ['trained group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hagar El-Hadidy, lecturer', 'role': 'CONTACT', 'email': 'hagarhadidy2016@gmail.com'}], 'facility': 'Ahram canadian university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'hagar El-Hadidy, lecturer', 'role': 'CONTACT', 'email': 'hagarhadidy2016@gmail.com', 'phone': '01007453552'}, {'name': 'omnia mahmoud', 'role': 'CONTACT', 'email': 'omniasaeedmahmoud2021@gmail.com', 'phone': '01227805225'}], 'overallOfficials': [{'name': 'hagar El-Hadidy, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ahram Canadian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Internal Medicine and Geriatrics', 'investigatorFullName': 'Hagar Ahmed El-Hadidy', 'investigatorAffiliation': 'Ahram Canadian University'}}}}