Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 11:44 AM
Study NCT ID:
NCT02712294
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance in six-minute walk test', 'timeFrame': 'change from baseline in distance at 2 months', 'description': 'analysis of distance'}, {'measure': 'Oxygen saturation in six-minute walk test', 'timeFrame': 'change from baseline in oxygen saturation at 2 months', 'description': 'analysis of oxygen saturation at end of test'}, {'measure': 'Systolic blood pressure in six-minute walk test', 'timeFrame': 'change from baseline in systolic blood pressure at 2 months', 'description': 'analysis of systolic blood pressure at end of test'}, {'measure': 'Diastolic blood pressure in six-minute walk test', 'timeFrame': 'change from baseline in diastolic blood pressure at 2 months', 'description': 'analysis of diastolic blood pressure at end of test'}, {'measure': 'Heart rate in six-minute walk test', 'timeFrame': 'change from baseline in heart rate at 2 months', 'description': 'analysis of heart rate at end of test'}, {'measure': 'Borg scale in six-minute walk test', 'timeFrame': 'change from baseline in Borg scale at 2 months', 'description': 'analysis of Borg scale at end of test'}], 'secondaryOutcomes': [{'measure': 'The Medical Outcomes Study 36-item Short Form Health Survey', 'timeFrame': 'change from baseline at 2 months', 'description': 'The questionnaire covers 36 items, designed to assess health concepts'}, {'measure': 'Forced vital capacity', 'timeFrame': 'change from baseline at 2 months', 'description': 'spirometric analysis'}, {'measure': 'Forced expiratory volume in the first second', 'timeFrame': 'change from baseline at 2 months', 'description': 'spirometric analysis'}, {'measure': 'Forced expiratory flow 25-75 %', 'timeFrame': 'change from baseline at 2 months', 'description': 'spirometric analysis'}, {'measure': 'Ratio of forced expiratory volume in the first second and forced vital capacity', 'timeFrame': 'change from baseline at 2 months', 'description': 'spirometric analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'peripheral muscle electrostimulation', 'capacity of the exercises', 'quality of life'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.\n\nNon-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.\n\nObjective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.\n\nMaterial and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.\n\nResults: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.\n\nConclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMales and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.\n\nExclusion Criteria:\n\nExclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.'}, 'identificationModule': {'nctId': 'NCT02712294', 'briefTitle': 'Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'Parece 517.472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group (GC)', 'description': 'The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol.'}, {'type': 'EXPERIMENTAL', 'label': 'NMES Group (GE)', 'description': 'Receiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator. Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ. The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds.', 'interventionNames': ['Other: Neuromuscular Electrical Stimulation']}], 'interventions': [{'name': 'Neuromuscular Electrical Stimulation', 'type': 'OTHER', 'armGroupLabels': ['NMES Group (GE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01221-020', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Profa. Dra. Vera Lúcia dos Santos Alves', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}