Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05267067
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2022-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2022-02-13', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '3 month', 'description': 'By respiratory pressure meter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiration Disorders']}, 'descriptionModule': {'briefSummary': 'Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.', 'detailedDescription': 'Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients\n* underwent valve surgery (repair or replacement) for mitral valve stenosis;\n* hemodynamically stable,\n* ages ranged from 12 to 18 years old-\n* BMI ranges from 18.5 to 24.9\n* reduced MEP, MVV and complaining from shortness of breath with exertion.\n\nExclusion Criteria:\n\n* Patients with previous cardiac surgery\n* congenital heart disease\n* neurological disorders\n* type1 diabetes mellitus\n* smoker\n* pacemaker implantation\n* atrial fibrillation\n* utilization of mechanical ventilation longer than 24 hours.'}, 'identificationModule': {'nctId': 'NCT05267067', 'briefTitle': 'Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter', 'orgStudyIdInfo': {'id': 'Chest physiotherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'manual respirtory exercises', 'description': 'Using manual traditional respiratory exercises.', 'interventionNames': ['Other: respiratory exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Respiratory exercises with respiratory pressure meter', 'description': 'Using pressure respiratory meter in exercises.', 'interventionNames': ['Other: respiratory exercises']}], 'interventions': [{'name': 'respiratory exercises', 'type': 'OTHER', 'description': 'Manual respiratory exercises versus respiratory exercises with pressure meter', 'armGroupLabels': ['Respiratory exercises with respiratory pressure meter', 'manual respirtory exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11431', 'city': 'Cairo', 'state': 'Select State/province', 'country': 'Egypt', 'facility': 'Sahar Abdalbary', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abdallaha Mohamed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nahda University, Faculty of Physical Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sahar Ahmed Abdalbary', 'investigatorAffiliation': 'Cairo University'}}}}