Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02584205
Status:
UNKNOWN
Last Update Posted:
2015-10-22
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal oxygen uptake after inspiratory muscle training', 'timeFrame': 'twelve weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inspiratory muscle training', 'obstructive sleep apnea', 'functional capacity'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles. Therefore, the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA. A pilot study will be conducted to calculate the sample. Individuals of both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by polysomnography) will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study deals with a test-clinical randomized double-blind.The intervention groups held inspiratory muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will be submitted to a simulated training with load less than 10% of MIP (insufficient charge to train the muscles), during the same period as the intervention group. The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the training period, the groups will be reassessed by the evaluation tests of functional capacity (ADL- Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung function (spirometry) and then compared. Expected results: The interventional groups will improve their functional capacity.', 'detailedDescription': 'Introduction: Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles. The inspiratory muscle training (IMT) has improved exercise tolerance in other cardiopulmonary diseases such as chronic obstructive pulmonary disease and heart failure. Objectives: Therefore, the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA. Patients and Methods: A pilot study will be conducted to calculate the sample. Individuals of both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by polysomnography) will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study deals with a test-clinical randomized double-blind to be held in four groups: A) Patients with OSA and Obesity - intervention, B) Patients with OSA and Obesity - control, C) Patients with OSA eutrophic - intervention , D) Patients with OSA eutrophic - control. The intervention groups held inspiratory muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will be submitted to a simulated training with load less than 10% of MIP (insufficient charge to train the muscles), during the same period as the intervention group. The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the training period, the groups will be reassessed by the evaluation tests of functional capacity (ADL-Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung function (spirometry) and then compared. Expected results: The interventional groups will improve their functional capacity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with OSA (moderate or severe) diagnosed by polysomnography;\n* Age between 40 and 65;\n* Who are qualified to perform the stress tests to assess functional capacity;\n* Individuals with BMI ≥ 18 ≤ 39.9 kg / m2.\n\nExclusion Criteria:\n\n* Patients who are making use of non-invasive ventilation;\n* Patients who report on your medical history, orthopedic problems, neurological or cardiovascular or respiratory disease which may cause limitation of functional capacity;\n* Patients with BMI\\> 40 kg / m2.'}, 'identificationModule': {'nctId': 'NCT02584205', 'briefTitle': 'Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea?', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea? Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '36660314.8.0000.5208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Powerbreathe', 'description': 'We will use the powerbreathe Classic light resistance in this intervention (inspiratory muscle training). Both groups will receive the equipment, but the intervention group will do the training with a load 40% of the maximum inspiratory pressure.', 'interventionNames': ['Device: Powerbreathe']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This group will also receive the equipment (powerbreathe classic light) but will do the "training" with a load less than 10% of the maximum inspiratory pressure (insufficient charge to train the muscles).', 'interventionNames': ['Device: Powerbreathe']}], 'interventions': [{'name': 'Powerbreathe', 'type': 'DEVICE', 'description': 'In this intervention we will use an equipment called "powerbreathe classic light". It provides us to choose resistance levels with an adjustable load setting range: 1 to 9 and it\'s ideal for beginners. In this research we will use it on the intervention group to improve the strength of inspiratory muscle training and evaluate the results in the functional capacity of the subjects with obstructive sleep apnea.', 'armGroupLabels': ['Control', 'Powerbreathe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Adília KF Souza, Mastering', 'role': 'CONTACT', 'email': 'adiliakaroline@hotmail.com', 'phone': '55 81 9564 8415'}, {'name': 'Adília KF Souza, Mastering', 'role': 'CONTACT', 'email': 'adiliakfsfisio@gmail.com', 'phone': '55 83 9671 8345'}], 'facility': 'Adília Karoline Ferreira Souza', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'centralContacts': [{'name': 'Adília KF Souza, Mastering', 'role': 'CONTACT', 'email': 'adiliakaroline@hotmail.com', 'phone': '55 81 9564 8415'}, {'name': 'Adilia KF Souza, Mastering', 'role': 'CONTACT', 'email': 'adiliakfsfisio@gmail.com', 'phone': '55 83 9671 8345'}], 'overallOfficials': [{'name': 'Adília KF Souza, Mastering', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UFPE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adília Karoline Ferreira Souza', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}