Nctid:
NCT06223802
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001851", "term"=>"Bone Diseases, Metabolic"}, {"id"=>"D000006461", "term"=>"Hemolysis"}], "ancestors"=>[{"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M9547", "name"=>"Hemolysis", "asFound"=>"Hemolysis", "relevance"=>"HIGH"}, {"id"=>"M5130", "name"=>"Bone Diseases, Metabolic", "asFound"=>"Osteopenia", "relevance"=>"HIGH"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}}, "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"=>30.00808, "lon"=>31.21093}}], "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"}}}}
