Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT05803967
Status:
UNKNOWN
Last Update Posted:
2023-04-07
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thyroid stimulating hormone', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured in serum of women with hypothyroidism'}], 'secondaryOutcomes': [{'measure': 'systolic blood pressure', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured by manual sphygmomanometer'}, {'measure': 'triglycerides', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured in serum of women with hypothyroidism'}, {'measure': 'Addenbrooke Cognitive Examination', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will assess Cognitive impairment'}, {'measure': 'diastolic blood pressure', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured by manual sphygmomanometer'}, {'measure': 'low density lipoprotein', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured in serum of women with hypothyroidism'}, {'measure': 'cholesterol', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured in serum of women with hypothyroidism'}, {'measure': 'high density lipoprotein', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'will be measured in serum of women with hypothyroidism'}, {'measure': 'body mass index', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it will be measure on empty bladder and stomach'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subclinical hypothyroïdism', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly', 'detailedDescription': 'Females (forty in number) with sub-clinical hypothyroidism exhibit cognitive problems, they are elderly, will be divided to exercised group (baduanjin training will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20) and other non exercised group (number of patients will be 20) . all women of groups will received their prescribed daily one-dose medication tablet (levothyroxine).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female with sub-clinical hypothyroidism\n* females with mild cognitive impairment\n* females with obesity (obesity class one)\n\nExclusion Criteria:\n\n* neurological problems\n* orthopedic problems'}, 'identificationModule': {'nctId': 'NCT05803967', 'briefTitle': 'Baduanjin Exercising Effects on Sub-clinical Hypothyroidism and Cognitive Problems', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Baduanjin Exercising Effects on Women With Hypothyroidism and Cognitive Problems', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group number 1', 'description': 'Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive baduanjin training that will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20), also women of this group will receive their prescribed daily one-dose medication tablet (levothyroxine).', 'interventionNames': ['Behavioral: Baduanjin exercising']}, {'type': 'NO_INTERVENTION', 'label': 'group number 2', 'description': 'Females with sub-clinical hypothyroidism exhibit cognitive problems (mild cognitive impairement), they will be elderly, will receive will receive their prescribed daily one-dose medication tablet (levothyroxine).'}], 'interventions': [{'name': 'Baduanjin exercising', 'type': 'BEHAVIORAL', 'description': 'baduanjin will be applied 5 times per the week, under supervision, for 12 weeks,', 'armGroupLabels': ['group number 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '01005154209'}], 'facility': 'Cairo Unoversity', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali MA Ismail', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '01005154209'}, {'name': 'mona MA morsi', 'role': 'CONTACT', 'email': 'allooka2012@yahoo.com', 'phone': '01006372646'}], 'overallOfficials': [{'name': 'Ali MA Ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Internal Medicine and Geriatrics', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}