Nctid:
NCT06224465
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11577", "name"=>"Menopause, Premature", "relevance"=>"LOW"}, {"id"=>"M19020", "name"=>"Primary Ovarian Insufficiency", "relevance"=>"LOW"}, {"id"=>"T6036", "name"=>"Menopause", "asFound"=>"Menopause", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"intervention: aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2)Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repeatation for each exercise three times per week.\n\nTheraband exercises for upper limb exercise ten repeatation for each exercise three times per week.\n\n3) Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week.\n\nLateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-04-20", "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"=>"2024-04-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"6-minute walking test", "timeFrame"=>"period of the treatment will 3 successive months", "description"=>"The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity."}, {"measure"=>"sit reach test", "timeFrame"=>"period of the treatment will 3 successive months", "description"=>"his test only measures the flexibility of the lower back and hamstrings, and is a valid measure of this.The sit and reach test is a common test of flexibility, and is an easy and quick test to perform. If using the standard testing procedure, there is a lot of published data to use for comparison."}, {"measure"=>"hand held dynamometer", "timeFrame"=>"eriod of the treatment will 3 successive months", "description"=>"Hand held dynamometer demonstrated an excellent intra- and inter-rater reliability for assessment of isometric lumbar muscles strength of healthy subject at clinical setting as it is simple to use, portable and cost-effective for the precise measurement."}, {"measure"=>"body composition analysis", "timeFrame"=>"period of the treatment will 3 successive months", "description"=>"Body composition is a method of describing what the body is made of. It includes fat, protein, minerals and body water. It also describes weight more accurately than BMI. Body composition analysis can accurately show changes in fat mass, muscle mass, and body fat percentage. This can help validate services"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["healthy antiaging", "premenopausal fitness enchancement", "cardiovascular training", "diet instruction"], "conditions"=>["Menopause Early"]}, "descriptionModule"=>{"briefSummary"=>"Aging is an important fact to consider from the woman's health perspective. One of the most significant stages of aging is menopause, in which involves physical, psychological, and social changes in life", "detailedDescription"=>"This study will be carried on forty perimenopausal women, They will be selected randomly from outpatient clinic of El Kaser El-Einy University Hospital ,Cairo Uninversity, their age ranged from 40 to 50years.\n\nGroup A ( Experimental group): It will be consisted of 20 pre menopausal women.They will receive Antiaging therapy ( Aerobic ,Flexibility and strengthening exercises ) with anti aging diet instructions.\n\nGroup B ( Control group):\n\nIt will be consisted of 20 perimenopausal women. They will receive anti aging diet instructions.\n\nRandomization:\n\nRandomization of sample selection will be achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop will contain a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman will attend to the group according the name of the group written in her envelop."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 1-They complaining from fatigue ,hot flues and irregular period. 2- Their Body Mass Index (BMI) between 25 to 30 . 3-Their age ranged from 40 to 50 years old. 4-The assessment procedures will be conducted on the same time of the day pre/post treatment.\n\nExclusion Criteria:\n\n* Womens with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.\n\n 2. Women received medications that might affect the neuromuscular functions at least three months before or during the study course.\n\n 3. Women suffered from mental or psychological disorders. 4. Women suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.\n\n 5. Women are not complaining from osteoporosis."}, "identificationModule"=>{"nctId"=>"NCT06224465", "briefTitle"=>"Effect of Anti Aging on Fitness Enhancement in Premenopausal Women", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Effect of Anti Aging on Fitness Enhancement in Premenopausal Women", "orgStudyIdInfo"=>{"id"=>"premenopausal women"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"control group", "description"=>"Antiaging diet instructions", "interventionNames"=>["Other: aerobic exercises"]}, {"type"=>"EXPERIMENTAL", "label"=>"intervention group", "description"=>"1. aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks\n2. Muscle strength Exercises:\n\n For upper extremity : hand grip exercise, arm flexion exercise ten repeatation for each exercise three times per week.\n\n Theraband exercises for upper limb exercise ten repeatation for each exercise three times per week.\n3. Flexibility Exercise :\n\nCurl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week.\n\nLateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks and anti aging diet instruction", "interventionNames"=>["Other: aerobic exercises"]}], "interventions"=>[{"name"=>"aerobic exercises", "type"=>"OTHER", "otherNames"=>["flexibility exercises", "strengthening exercises", "anti aging diet instrustion"], "description"=>"Antiaging diet instruction :Be aware of the amount of calories, Reduce overall fat and sugar intake, Drink at least 10 glasses of water every day in order to remain healthy.\n\nd. Eat a variety of complex carbohydrates and vegetables instead of bread, rice, and corn.", "armGroupLabels"=>["control group", "intervention group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12662", "city"=>"Giza", "country"=>"Egypt", "contacts"=>[{"name"=>"suzy Nazmy, master", "role"=>"CONTACT", "email"=>"markm192015@gmail.com", "phone"=>"01211397971"}], "facility"=>"faculty of physical therapy ,Cairo University", "geoPoint"=>{"lat"=>30.00808, "lon"=>31.21093}}], "centralContacts"=>[{"name"=>"suzy Nazmy, master", "role"=>"CONTACT", "email"=>"info@pt.cu.edu.eg", "phone"=>"01211397971"}], "overallOfficials"=>[{"name"=>"Amel YOUSEF", "role"=>"STUDY_CHAIR", "affiliation"=>"Cairo University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Suzy Samih Nazmy", "investigatorAffiliation"=>"Cairo University"}}}}
