Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 12:15 PM
Study NCT ID:
NCT05212558
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor was blinded to the treatment allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A randomized, placebo-controlled, assessor-blinded clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory muscle strength', 'timeFrame': '2 months', 'description': 'Inspiratory muscle strength was assessed by measuring the maximal inspiratory pressure (reflects the strength of the diaphragm and other inspiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.'}, {'measure': 'Expiratory muscle strength', 'timeFrame': '2 months', 'description': 'Expiratory muscle strength was assessed by measuring the maximal expiratory pressure (reflects the strength of the abdominal muscles and other expiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.'}, {'measure': 'Forced vital capacity', 'timeFrame': '2 months', 'description': 'Forced vital capacity, which is the amount of air that each participant was able to forcibly exhale from his/her lungs after taking the deepest breath they can, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.'}, {'measure': 'Forced expiratory volume in one second', 'timeFrame': '2 months', 'description': 'Forced expiratory volume in one second, which is the volume of air exhaled in the first second during forced exhalation after a maximal inspiration, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.'}, {'measure': 'Forced expiratory volume in one second / forced vital capacity', 'timeFrame': '2 months', 'description': 'Forced expiratory volume in one second / forced vital capacity, is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.'}], 'secondaryOutcomes': [{'measure': 'Asthma symptoms', 'timeFrame': '2 months', 'description': 'A translated version of the asthma control test was used to assess the degree of control over asthma symptoms. The test is patient-administered consists of 5 items. Each item has five possible responses (1: not controlled and 5: completely controlled). the test score ranges from 5 (inadequate control) to 25 (optimal control).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Respiratory Diseases', 'Respiratory Therapy', 'Chest Physiotherapy', 'Pulmonary Functions', 'Asthma', 'Respiratory Muscle Training'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the effect of inspiratory and expiratory muscle training in the same cycle on respiratory muscle strength, pulmonary functions, perception of asthma symptoms in children with bronchial asthma. Fifty-one children with bronchial asthma were randomly allocated to the unloaded respiratory muscle training (Placebo training group; n = 17), inspiratory muscle training alone (inspiratory muscle training group; n = 17), or combined inspiratory and expiratory muscle training in the same cycle (combined training group; n = 17). All groups were assessed for respiratory muscle strength, pulmonary functions, and asthma symptoms.', 'detailedDescription': 'Fifty-one children with bronchial asthma were recruited from King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included children who had a confirmed diagnosis of bronchial asthma according to the Global Initiative for Asthma guidelines, aged 12-18 years, identified as being stable cases, had a baseline percent-predicted value of the peak expiratory flow rate of 60-80%, sustained stale doses of medications in the past three months. Children who had unstable asthma or exacerbated asthma symptoms, history of thoracic surgery, or cardiopulmonary comorbidities were excluded.\n\nOutcome measures\n\n1. Respiratory muscle strength: assessed by measuring the maximal inspiratory and expiratory pressure using an electronic respiratory pressure meter.\n2. Pulmonary function: The forced vital capacity (FVC), forced expiratory volume in the first second of expiration (FEV1), and FEV1/FVC ratio, were measured in a pulmonary function test through a spirometry analyzer.\n3. Control of asthma symptoms: Asthma symptoms were assessed using a translated version of the asthma control test.\n\nAll groups received the conventional respiratory re-training program, three times a week, for 12 weeks in succession. The placebo group additionally received unloaded respiratory muscle training, the inspiratory muscle training group received respiratory muscle training alone, and the combined group received combined inspiratory and expiratory muscle training in the same cycle. Interventions were conducted by a licensed physical therapist who had experience of more than 10 years of respiratory training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of asthma according to Global Initiative of Asthma guidelines.\n* Age between 12 and 18 years.\n* Clinically stable asthma.\n* Stable doses of medications in the last three months\n* A percent-predicted value of the peak expiratory flow rate of 60-80%\n* No activity limitation due to asthma\n\nExclusion Criteria:\n\n* Unstable asthma\n* Exacerbation of asthma symptoms\n* History of thoracic surgery\n* Cognitive/behavioral problems\n* Cardiopulmonary co-morbidities'}, 'identificationModule': {'nctId': 'NCT05212558', 'briefTitle': 'Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Rationale of Applying Inspiratory/Expiratory Muscle Training Within the Same Respiratory Cycle in Children With Bronchial Asthma: A Placebo-controlled Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RHPT/0020/0061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'This group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training', 'interventionNames': ['Other: Placebo respiratory muscle training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inspiratory muscle training group', 'description': 'This group received a conventional respiratory retraining program plus inspiratory muscle training only', 'interventionNames': ['Other: Inspiratory muscle training']}, {'type': 'EXPERIMENTAL', 'label': 'Combined training group', 'description': 'This group received a conventional respiratory retraining program plus inspiratory and expiratory muscle training in the same respiratory cycle.', 'interventionNames': ['Other: Combined inspiratory and expiratory muscle training']}], 'interventions': [{'name': 'Placebo respiratory muscle training', 'type': 'OTHER', 'description': 'Unloaded respiratory muscle training plus conventional respiratory exercises', 'armGroupLabels': ['Placebo group']}, {'name': 'Inspiratory muscle training', 'type': 'OTHER', 'description': 'Inspiratory muscle training plus conventional respiratory exercises', 'armGroupLabels': ['Inspiratory muscle training group']}, {'name': 'Combined inspiratory and expiratory muscle training', 'type': 'OTHER', 'description': 'Combined inspiratory and expiratory muscle training in the same respiratory cycle plus conventional respiratory exercises.', 'armGroupLabels': ['Combined training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Ragab K. Elnaggar', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Ragab K Elnaggar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince Sattam Bin Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ragab Kamal Elnaggar', 'investigatorAffiliation': 'Cairo University'}}}}