Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 10:47 PM
Study NCT ID:
NCT04949334
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle function-1.1', 'timeFrame': 'Baseline', 'description': 'MEP (maximal expiratory pressure)'}, {'measure': 'Respiratory muscle function-1.2', 'timeFrame': 'Within one week after training', 'description': 'MEP (maximal expiratory pressure)'}, {'measure': 'Respiratory muscle function-1.3', 'timeFrame': 'Twelve weeks after training', 'description': 'MEP (maximal expiratory pressure)'}, {'measure': 'Respiratory muscle function-2.1', 'timeFrame': 'Baseline', 'description': 'MIP (maximal inspiratory pressure)'}, {'measure': 'Respiratory muscle function-2.2', 'timeFrame': 'Within one week after training', 'description': 'MIP (maximal inspiratory pressure)'}, {'measure': 'Respiratory muscle function-2.3', 'timeFrame': 'Twelve weeks after training', 'description': 'MIP (maximal inspiratory pressure)'}], 'secondaryOutcomes': [{'measure': 'Dyspnea.1', 'timeFrame': 'Baseline', 'description': 'Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.'}, {'measure': 'Dyspnea.2', 'timeFrame': 'Within one week after training', 'description': 'Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.'}, {'measure': 'Dyspnea.3', 'timeFrame': 'Twelve weeks after training', 'description': 'Dyspnea assessed by Modified Borg Dyspnea Scale (MBS). MBS can go from 0-10, 10 is the more severe condition.'}, {'measure': 'Exercise tolerance.1', 'timeFrame': 'Baseline', 'description': 'Exercise tolerance assessed by six-minute walk test (6MWT).'}, {'measure': 'Exercise tolerance.2', 'timeFrame': 'Within one week after training', 'description': 'Exercise tolerance assessed by six-minute walk test (6MWT).'}, {'measure': 'Exercise tolerance.3', 'timeFrame': 'Twelve weeks after training', 'description': 'Exercise tolerance assessed by six-minute walk test (6MWT).'}, {'measure': 'Body composition.1', 'timeFrame': 'Baseline', 'description': 'Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).'}, {'measure': 'Body composition.2', 'timeFrame': 'Within one week after training', 'description': 'Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).'}, {'measure': 'Body composition.3', 'timeFrame': 'Twelve weeks after training', 'description': 'Body composition including body fat and muscle mass measured by multi frequency segmental body composition analyzer (TANITA).'}, {'measure': 'Life quality.1', 'timeFrame': 'Baseline', 'description': 'Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.'}, {'measure': 'Life quality.2', 'timeFrame': 'Within one week after training', 'description': 'Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.'}, {'measure': 'Life quality.3', 'timeFrame': 'Twelve weeks after training', 'description': 'Quality of life assessed by Short-form 12 (SF-12). SF-12 can go from 0-100, 100 is the better life quality.'}, {'measure': 'Swallowing.1', 'timeFrame': 'Baseline', 'description': 'Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.'}, {'measure': 'Swallowing.2', 'timeFrame': 'Within one week after training', 'description': 'Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.'}, {'measure': 'Swallowing.3', 'timeFrame': 'Twelve weeks after training', 'description': 'Swallowing function assessed by the Functional Oral Intake Scale (FOIS). The score can go from 1-7, 7 is the better oral intake condition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Respiratory muscle training', 'Respiratory function'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.', 'detailedDescription': 'After acute ischemic stroke, the muscle strength of the limbs of the patients will decrease. Moreover, the respiratory muscles may also be affected. The worsening of the respiratory function is weakened and lung function declines, leading to dysfunction of expectoration and swallowing, and increasing the incidence of pneumonia after stroke. In addition, it will also lead to a decline in activity ability, which in turn affects the quality of life. The respiratory muscle training may improve the respiratory recovery and prevent pulmonary complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic stroke diagnosed by MRI\n2. Age over 20 years old\n3. No worsening of stroke or second stroke this time\n\nExclusion Criteria:\n\n1. Unable to understand instructions normally, or communication difficulties\n2. Patients with endotracheal tube or tracheostomy\n3. Angina in recent 3 months, myocardial infarction, heart failure\n4. Patients with asthma or chronic obstructive pulmonary disease, spontaneous pneumothorax, and ongoing pneumonia\n5. Patients with untreated hernias\n6. Pregnant\n7. Ongoing fever (body temperature\\>38.5°C)\n8. Poor hypertension control (higher than 170/100 mmHg three days before intervention)\n9. Patients who have had cerebral hemorrhage or aneurysm'}, 'identificationModule': {'nctId': 'NCT04949334', 'briefTitle': 'Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'Effects of Respiratory Muscle Training in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'N202009012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dofin Breathing Strength Builder', 'description': 'Usual post stroke care and respiratory muscle training', 'interventionNames': ['Device: Dofin Breathing Strength Builder']}, {'type': 'NO_INTERVENTION', 'label': 'Usual post stroke care', 'description': 'Usual post stroke care'}], 'interventions': [{'name': 'Dofin Breathing Strength Builder', 'type': 'DEVICE', 'description': "If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks.\n\nThe initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O.", 'armGroupLabels': ['Dofin Breathing Strength Builder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ruey Chen, PhD', 'role': 'CONTACT', 'email': '18622@s.tmu.edu.tw', 'phone': '886-2-2249088', 'phoneExt': '8620'}, {'name': 'Tzu-Ang Chen, MD', 'role': 'CONTACT', 'email': 'b101103035@tmu.edu.tw', 'phone': '886-915855505'}], 'facility': 'Shuang Ho Hospital, Taipei Medical University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ruey Chen, PhD', 'role': 'CONTACT', 'email': '18622@s.tmu.edu.tw', 'phone': '886-2-2249088', 'phoneExt': '8620'}, {'name': 'Tzu-Ang Chen, MD', 'role': 'CONTACT', 'email': 'b101103035@tmu.edu.tw', 'phone': '886-915855505'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Chen ruey', 'investigatorAffiliation': 'Taipei Medical University Shuang Ho Hospital'}}}}