Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 4:26 AM
Study NCT ID:
NCT04123132
Status:
UNKNOWN
Last Update Posted:
2020-01-10
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Kinesophobia in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': '3 months', 'description': 'People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kinesiophobia', 'metabolic syndrome', 'exercise'], 'conditions': ['Kinesiophobia', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS.\n\nPatients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45-65 years old men and female with metabolic syndrome and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metabolic syndrome\n\nExclusion Criteria:\n\n* Patients with rheumatic disease\n* Patients with neurologic disease\n* Patients with history of trauma\n* Patients with gonartrosis\n* Pateints with fibromialgia'}, 'identificationModule': {'nctId': 'NCT04123132', 'briefTitle': 'Evaluation of Kinesophobia in Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Erol Olcok Corum Training and Research Hospital'}, 'officialTitle': 'Evaluation of Kinesophobia in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': '08090081DEB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with metabolic syndrome', 'interventionNames': ['Other: Kinesiophobia']}, {'label': 'Healthy controls'}], 'interventions': [{'name': 'Kinesiophobia', 'type': 'OTHER', 'description': 'The presence of kinesiofobia in patients with metabolic syndrome', 'armGroupLabels': ['Patients with metabolic syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Çorum', 'state': 'Central Anatolia', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Dilek E Büyükşireci', 'role': 'CONTACT', 'email': 'dilekeker55@gmail.com', 'phone': '5439196253'}, {'name': 'Dilek E Büyükşireci', 'role': 'CONTACT', 'email': 'dilekeker55@gmail.com', 'phone': '+905439196253'}], 'facility': 'Dilek Eker Büyükşireci', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}], 'centralContacts': [{'name': 'Dilek E Büyükşireci', 'role': 'CONTACT', 'email': 'dilekeker55@gmail.com', 'phone': '+905439196253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erol Olcok Corum Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist doctor', 'investigatorFullName': 'Dilek Eker Büyükşireci', 'investigatorAffiliation': 'Erol Olcok Corum Training and Research Hospital'}}}}