Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 4:55 PM
Study NCT ID:
NCT04397133
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2019-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'], 'maskingDescription': 'the assessor who will investigate the results and the investigator who will perform the MIP and 6-minutes walking test will be blinded to the randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'three armed study with two interventions and one control group intervention group 1: inspiratory muscle training applied for 4 week intervention group 2: inspiratory muscle training applied for 8 week control group : will get sham intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-20', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2020-05-17', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in maximal inspiratory pressure', 'timeFrame': 'Baseline and week 8,12, 24', 'description': 'Measured with MicroRPM (respiratory pressure meter) pressurometer device orally'}], 'secondaryOutcomes': [{'measure': 'The change in walking capacity', 'timeFrame': 'Baseline and week 8,12, 24', 'description': 'The change in walking capacity wil be measured with Six Minute Walk Test'}, {'measure': 'Pneumonia incidence', 'timeFrame': 'Week 24', 'description': 'Number of participants with Pneumonia will be determined at week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breathing exercises', 'Cerebrovascular disease', 'Muscle strength', 'Rehabilitation', 'Stroke'], 'conditions': ['Stroke, Complication', 'Respiratory Complication']}, 'referencesModule': {'references': [{'pmid': '22568454', 'type': 'BACKGROUND', 'citation': 'Pollock RD, Rafferty GF, Moxham J, Kalra L. Respiratory muscle strength and training in stroke and neurology: a systematic review. Int J Stroke. 2013 Feb;8(2):124-30. doi: 10.1111/j.1747-4949.2012.00811.x. Epub 2012 May 9.'}, {'pmid': '21272713', 'type': 'BACKGROUND', 'citation': 'Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029.'}, {'pmid': '27271373', 'type': 'BACKGROUND', 'citation': 'Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7.'}, {'pmid': '21876848', 'type': 'BACKGROUND', 'citation': 'Billinger SA, Coughenour E, Mackay-Lyons MJ, Ivey FM. Reduced cardiorespiratory fitness after stroke: biological consequences and exercise-induced adaptations. Stroke Res Treat. 2012;2012:959120. doi: 10.1155/2012/959120. Epub 2011 Aug 14.'}, {'pmid': '20156979', 'type': 'BACKGROUND', 'citation': 'Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.'}, {'pmid': '12601102', 'type': 'BACKGROUND', 'citation': 'Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology. 2003 Feb 25;60(4):620-5. doi: 10.1212/01.wnl.0000046586.38284.60.'}]}, 'descriptionModule': {'briefSummary': 'The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( IMT ) exercises groups and control groups in stroke survivors. The secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups', 'detailedDescription': 'Stroke is one of the leading causes of death and disability. It is not only because of loss of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature.\n\nThe study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since it is the expected value in normal people.\n\nAfter admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking test will be done. In intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold IMT device every weekday. And in control group, the patients will get sham intervention for 8 weeks. The MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week we will record the pneumonia incidence if occured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic/ hemorrhagic stroke\n* Stroke duration\\> 3 months\n* Age\\> 18 years old\n* Baseline maximal inspiratory pressure below 80 cmH2O\n\nExclusion Criteria:\n\n* Cognitive deficiency\n* Facial paralysis\n* Chronic obstructive pulmonary disease\n* Congestive heart disease\n* Myocardial infarction in last three months\n* Angina pectoris'}, 'identificationModule': {'nctId': 'NCT04397133', 'briefTitle': 'The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients: A Double-blind Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'IstPMRTRH-IMT-H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention 1', 'description': 'in this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)', 'interventionNames': ['Other: inspiratory muscle training']}, {'type': 'EXPERIMENTAL', 'label': 'intervention 2', 'description': 'in this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)', 'interventionNames': ['Other: inspiratory muscle training']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'this group will get sham intervention with 0 to 5 cmH2O resistance', 'interventionNames': ['Other: sham intervention']}], 'interventions': [{'name': 'inspiratory muscle training', 'type': 'OTHER', 'description': 'inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value', 'armGroupLabels': ['intervention 1', 'intervention 2']}, {'name': 'sham intervention', 'type': 'OTHER', 'description': 'in these group the patients will get sham intervention with Philips Respironics Threshold IMT device', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine Rehabilitation Traning and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yunus Emre Doğan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine Rehabilitation Traning and Research Hospital'}, {'name': 'Burak Kütük, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine Rehabilitation Traning and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Istanbul Saglik Bilimleri University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}