Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 7:36 AM
Study NCT ID:
NCT03385733
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mouth pressures', 'timeFrame': '10 minutes', 'description': 'MIP and MEP'}], 'secondaryOutcomes': [{'measure': 'International Physical Activity Questionnaire-Short Form', 'timeFrame': '10 minutes', 'description': 'Physical activity'}, {'measure': 'Minnesota Living with Heart Failure Questionnaire', 'timeFrame': '15 minutes', 'description': 'quality of life'}, {'measure': 'Activity monitoring (Sense wear® Armband)', 'timeFrame': '3 days', 'description': 'Metabolic holter'}, {'measure': '6 minute walking test', 'timeFrame': '15 minutes', 'description': 'functional capacity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'inspiratory muscle training', 'functional capacity', 'physical activity'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.', 'detailedDescription': 'Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Pulmonary Hypertension,\n* NYHA functional class I-IV\n* MIP pressure \\<80 cm h2O\n\nExclusion Criteria:\n\n* COPD\n* Conditions which can limit the assessments\n* Insufficient cooperation'}, 'identificationModule': {'nctId': 'NCT03385733', 'briefTitle': 'Inspiratory Muscle Training in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'GAslan'}, 'secondaryIdInfos': [{'id': 'BuketA', 'type': 'OTHER', 'domain': 'BiruniU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory muscle training group', 'description': 'Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home.', 'interventionNames': ['Other: inspiratory muscle training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.'}], 'interventions': [{'name': 'inspiratory muscle training', 'type': 'OTHER', 'description': 'The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device', 'armGroupLabels': ['Inspiratory muscle training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Goksen Kuran Aslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results of the study will share with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biruni University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Proff.', 'investigatorFullName': 'Goksen Kuran Aslan', 'investigatorAffiliation': 'Istanbul University'}}}}