Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05723302
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2023-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HADS', 'timeFrame': '10 minutes', 'description': 'Hospital Anxiety Depression Scale'}], 'secondaryOutcomes': [{'measure': 'SGRQ', 'timeFrame': '15 minutes', 'description': "St George's Respiratory Questionnaire"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.', 'detailedDescription': 'The study was carried out between January 2017 and January 2019, with patients followed up with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of Helsinki. All participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. The study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined.\n\nThirty-five patients diagnosed with COPD were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants.\n\nThe 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. Patients meeting the inclusion criteria were divided into 2 groups. Randomized by ordering by date of application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be diagnosed with stage 1, stage 2 and stage 3 COPD according to GOLD (Global Initiative for Obstructive Lung Diseases) criteria\n* Having FEV1/FVC \\<70% according to pulmonary function test\n* Being clinically stable\n* Being over 18 years old\n* Volunteer to participate in the program\n\nExclusion Criteria:\n\n* Having a COPD exacerbation in the last 8 weeks\n* To have participated in a regular exercise training program in the last 1 year\n* Having a musculoskeletal disease and neuromuscular disease that may prevent exercise\n* Inability to cooperate for pulmonary function test and respiratory muscle strength measurement\n* Being on long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT05723302', 'briefTitle': 'Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effect of Resistant Proprioceptive Neuromuscular Facilitation Exercises on Respiratory Muscle Strength in Chronic Obstructive Pulmonary Diseases', 'orgStudyIdInfo': {'id': 'IstanbulMUH_1999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maximal Inspiratory Pressure', 'description': 'MIP Maximal Inspiratory Pressure', 'interventionNames': ['Diagnostic Test: MIP/MEP']}, {'type': 'EXPERIMENTAL', 'label': 'Maximal Expiratory Pressure', 'description': 'MEP Maximal Expiratory Pressure', 'interventionNames': ['Diagnostic Test: MIP/MEP']}], 'interventions': [{'name': 'MIP/MEP', 'type': 'DIAGNOSTIC_TEST', 'description': 'MIP/MEP', 'armGroupLabels': ['Maximal Expiratory Pressure', 'Maximal Inspiratory Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17100', 'city': 'Çanakkale', 'country': 'Turkey (Türkiye)', 'facility': 'Mehmet Akif Ersoy State Hospital', 'geoPoint': {'lat': 40.15552, 'lon': 26.41271}}, {'zip': '17100', 'city': 'Çanakkale', 'country': 'Turkey (Türkiye)', 'facility': 'Çanakkale Onsekiz Mart University', 'geoPoint': {'lat': 40.15552, 'lon': 26.41271}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mehmet Akif Ersoy Canakkale State Hospital', 'class': 'OTHER_GOV'}, {'name': 'Çanakkale Onsekiz Mart University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'sevda vurur', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}