Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-31 @ 1:17 AM
Study NCT ID:
NCT06870032
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Rehabilitation and Quality of Life in Children With Chronic Lung Diseases: A Multidisciplinary Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in One Second', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': 'FEV₁ is the volume of air that a person can forcefully exhale in the first second of a forced breath after taking a deep inhalation.\n\nInterpretation of FEV₁:\n\n≥80% of predicted → Normal 60-79% of predicted → Mild obstruction 40-59% of predicted → Moderate obstruction \\<40% of predicted → Severe obstruction'}, {'measure': 'Forced Vital Capacity', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': 'FVC is the total volume of air that can be forcefully exhaled after taking the deepest possible breath.\n\nNormal Values: Typically ≥80% of the predicted value. Obstructive Lung Disease: FVC may be normal or slightly reduced. Restrictive Lung Disease: FVC is significantly reduced due to decreased lung compliance or lung volume.'}, {'measure': 'Peak Expiratory Flow Rate', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': 'PEFR is the maximum speed of expiration achieved after full lung inflation. It is measured in liters per minute (L/min).\n\normal values depend on age, sex, and height: Adult males: 450-700 L/min Adult females: 300-500 L/min Reduced PEFR: Suggests airway obstruction, such as in asthma or COPD.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization Frequency', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': 'Hospitalization frequency refers to the number of times a patient is admitted to a hospital due to disease exacerbation, complications, or treatment failure.\n\nNumber of hospital admissions within a specific time frame (e.g., per year). Length of hospital stay (days per admission). Emergency department visits requiring inpatient care.'}, {'measure': 'Medication Dependency', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': 'Medication dependency refers to the extent to which a patient relies on pharmacological treatment to manage symptoms and maintain functional health.\n\nFrequency and dosage of medication use. Number of rescue medication uses (e.g., bronchodilators in asthma). Reduction or discontinuation of medication over time.'}, {'measure': 'Parental Satisfaction with Treatment', 'timeFrame': 'at basline and after 12-weeks of intervention', 'description': "Parental satisfaction refers to how parents perceive the effectiveness, convenience, and overall impact of their child's treatment plan.\n\nStandardized satisfaction surveys (e.g., Likert scale questionnaires). Interviews or focus groups with parents. Feedback on treatment effectiveness, side effects, accessibility, and ease of use."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lung Disease', 'Quality of Life', 'Respiratory Function Impaired']}, 'descriptionModule': {'briefSummary': "Chronic lung diseases (CLDs) such as asthma, cystic fibrosis, and bronchopulmonary dysplasia significantly impact pediatric patients' respiratory function and overall well-being. Pulmonary rehabilitation (PR) has been shown to improve lung function, exercise tolerance, and quality of life in affected individuals. However, limited research has been conducted on PR implementation in Egypt.", 'detailedDescription': 'Pulmonary rehabilitation significantly enhances respiratory function, exercise capacity, and quality of life in pediatric patients with CLDs while reducing healthcare utilization. These findings highlight the necessity of integrating structured PR programs into pediatric respiratory care in Egypt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed cases of CLDs, stable clinical condition, and ability to participate in rehabilitation.\n\nExclusion Criteria:\n\n* Severe comorbidities, recent respiratory infections, or contraindications to physical activity.'}, 'identificationModule': {'nctId': 'NCT06870032', 'briefTitle': 'Pulmonary Rehabilitation and Quality of Life in Children With Chronic Lung Diseases: A Multidisciplinary Approach', 'organization': {'class': 'OTHER', 'fullName': 'Horus University'}, 'officialTitle': 'The Impact of Pulmonary Rehabilitation on Respiratory Function and Quality of Life in Pediatric Patients With Chronic Lung Diseases: A Multidisciplinary Approach in Damietta Governorate', 'orgStudyIdInfo': {'id': 'PostDoc_012025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard medical care group', 'description': 'Patients receiving standard medical care without structured pulmonary rehabilitation.', 'interventionNames': ['Other: standard medical care']}, {'type': 'OTHER', 'label': 'structured pulmonary rehabilitation', 'description': 'The experimental group underwent a 12-week structured pulmonary rehabilitation program.', 'interventionNames': ['Other: structured pulmonary rehabilitation']}], 'interventions': [{'name': 'standard medical care', 'type': 'OTHER', 'description': 'standard medical care', 'armGroupLabels': ['standard medical care group']}, {'name': 'structured pulmonary rehabilitation', 'type': 'OTHER', 'description': 'structured pulmonary rehabilitation program including:\n\n* Physical Therapy: Breathing exercises, airway clearance techniques, inspiratory muscle training.\n* Pediatrics \\& Chest Medicine: Medical supervision, optimization of pharmacological treatment.\n* Physiology: Monitoring pulmonary function and physiological responses to exercise.\n* Public Health: Evaluating program feasibility and its impact on healthcare utilization.', 'armGroupLabels': ['structured pulmonary rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damietta', 'country': 'Egypt', 'facility': 'Out-patient Clinic, Faculty of Physical Therapy, Horus University', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}], 'overallOfficials': [{'name': 'Mohamed El-Sayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Horus University in Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Salah El-Sayed', 'investigatorAffiliation': 'Horus University'}}}}