Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-10 @ 1:28 AM
Study NCT ID:
NCT03102294
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2017-03-22
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': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity¨- cardiopulmonary exercise testing', 'timeFrame': 'week 8', 'description': 'TLim (seconds)'}, {'measure': 'exercise capacity - 6-min walk test', 'timeFrame': 'week 8', 'description': 'distance (m)'}], 'secondaryOutcomes': [{'measure': 'ventilatory responses', 'timeFrame': 'Week 8', 'description': 'VE/VCO2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Thromboembolic Pulmonary Hypertension', 'Inspiratory Muscle Training', 'Inspiratory Muscle Weakness', 'Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension.', 'detailedDescription': '32 patients with PH will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (\\~ 75% of maximal work-rate) and step test. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (\\~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CTEPH confirmed by RHC and imaging\n* NYHA FC II-IV\n\nExclusion Criteria:\n\n* Limitation to cycling\n* Recent syncope or clinical deterioration'}, 'identificationModule': {'nctId': 'NCT03102294', 'briefTitle': 'Inspiratory Muscle Training in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FUSaoPaulo2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental: IMT', 'description': 'inspiratory muscle training (PowerBREATHE) with \\~50% of maximum inspiratory pressure', 'interventionNames': ['Other: inspiratory muscle training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo: SHAM', 'description': 'inspiratory muscle training (PowerBREATHE) without inspiratory load', 'interventionNames': ['Other: Placebo "training"']}], 'interventions': [{'name': 'inspiratory muscle training', 'type': 'OTHER', 'description': 'inspiratory muscle training with 50% of MIP', 'armGroupLabels': ['Experimental: IMT']}, {'name': 'Placebo "training"', 'type': 'OTHER', 'description': 'placebo training with PowerBreathe (without inspiratory load)', 'armGroupLabels': ['Placebo: SHAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04127000', 'city': 'São Paulo', 'state': 'São Paul', 'country': 'Brazil', 'facility': 'SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Roberta Pulcheri Ramos', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}