Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-31 @ 5:04 PM
Study NCT ID:
NCT05056532
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-29', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pectoralis muscle strength', 'timeFrame': '15 minute', 'description': 'pectoralis muscle strength will be evaluated with hand held dynamometers according to muscle test technique'}, {'measure': 'serratus anterior muscle strength', 'timeFrame': '15 minutes', 'description': 'Serratus anterior muscle strength will be evaluated with hand held dynamometers according to muscle test technique'}, {'measure': 'sternocleidomasteoideus muscle strength', 'timeFrame': '15 minutes', 'description': 'sternocleidomasteoideus muscle strength will be evaluated with hand held dynamometers according to muscle test technique'}, {'measure': 'Respiratory mouth pressure', 'timeFrame': '15 minutes', 'description': 'Respiratory mouth pressure will be measured to determine maximally inspiratory pressure and maximally expiratory pressure according to ATS/ERS guidelines.'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Test (6MWT)', 'timeFrame': '30 minutes', 'description': 'Six minute walk test will be performed to evalute functionally exercise capacity according to ATS/ERS guidelines'}, {'measure': 'Dyspnea assessment', 'timeFrame': '20 minutes', 'description': 'London Chest Activity of Daily Living Scale will be used to sensation of dyspnea during activity of daily living.The scale consists of four domains: self-care (four items), domestic (six items), physical (two items) and leisure (three items). In total, the scale consisting of 15 items scored of 0 to 5. 0 means that "I wouldn\'t do anyway" and 5 means that "Someone else does it for me". Higher values indicate greater limitation due to the dyspnea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory muscle strength', 'exercise capacity', 'dyspnea', 'accessory respiratory muscle'], 'conditions': ['Pulmonary Artery Hypertension']}, 'referencesModule': {'references': [{'pmid': '26401245', 'type': 'BACKGROUND', 'citation': 'Panagiotou M, Peacock AJ, Johnson MK. Respiratory and limb muscle dysfunction in pulmonary arterial hypertension: a role for exercise training? Pulm Circ. 2015 Sep;5(3):424-34. doi: 10.1086/682431.'}, {'pmid': '32028638', 'type': 'BACKGROUND', 'citation': 'Riou M, Pizzimenti M, Enache I, Charloux A, Canuet M, Andres E, Talha S, Meyer A, Geny B. Skeletal and Respiratory Muscle Dysfunctions in Pulmonary Arterial Hypertension. J Clin Med. 2020 Feb 3;9(2):410. doi: 10.3390/jcm9020410.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is that evaluation of basic and accessory respiratory muscles and their relationship of six minute walk test in patient with pulmonary arterial hypertension (PAH)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient group will be chosen among the admitted to clinic control group will consist of invited volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with diagnosis of pulmonary arterial hypertension\n* patients with stabil drug therapy at least three months\n\nExclusion Criteria:\n\n* patients with obstructive and/ or restrictive lung disease comorbidity\n* severe orthopedic and/ or neurological comorbidity\n* patients with heart failure\n* patients with ischemic heart disease\n* uncooperative patients'}, 'identificationModule': {'nctId': 'NCT05056532', 'briefTitle': 'Evaluation of Respiratory Muscle in Patient With Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Giresun University'}, 'officialTitle': 'Evaluation of Primary and Accessory Respiratory Muscles and Their Influence on Exercise Capacity and Dyspnea in Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'PAH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients', 'description': 'Maximal mouth pressure will be evaluated for determine respiratory muscle strength, m. pectoralis, m. serratus anterior, m. sternocloideumasteoideus and quadriceps muscles strengths will be measured to evaluate accessory respiratory muscle strength, London chest activity of daily living scale will be done for assessment of dyspnea and six minute walk test will be used for determination of functionally capacity', 'interventionNames': ['Diagnostic Test: patient assessment']}, {'label': 'Control group', 'description': 'Maximal mouth pressure will be evaluated for determine respiratory muscle strength, m. pectoralis, m. serratus anterior, m. sternocloideumasteoideus and quadriceps muscles strengths will be measured to evaluate accessory respiratory muscle strength, London chest activity of daily living scale will be done for assessment of dyspnea and six minute walk test will be used for determination of functionally capacity', 'interventionNames': ['Diagnostic Test: patient assessment']}], 'interventions': [{'name': 'patient assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'subjective and objective measurement will be performed in patients with PAH', 'armGroupLabels': ['Control group', 'patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34096', 'city': 'Istanbul', 'state': 'Haseki', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul university-cerrahpasa cardiology institute', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Habibe DURDU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Giresun University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giresun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}