Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT06191367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2023-12-23', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function tests (PFTs).', 'timeFrame': 'Before and After the treatment program. "8 weeks"', 'description': "to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF."}, {'measure': 'Peripheral oxygen saturation level (SpO2).', 'timeFrame': 'Before and After the treatment program. "8 weeks"', 'description': 'measures the amount of oxygen carried in the blood stream in peripheral limbs.'}, {'measure': "Six minutes' walk distance test (6MWD).", 'timeFrame': 'Before and After the treatment program. "8 weeks"', 'description': 'measures the aerobic capacity of the lungs by testing the maximum distance the subject can walk in a 6 minutes time.'}, {'measure': 'Heart rate measurements. (HR).', 'timeFrame': 'through all the treatment procedures. "8 weeks"', 'description': 'it measures the number of heart bumps in a minute in order to deliver blood to all of the body during Rest and Activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Fibrosis Interstitial', 'Post-COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': 'the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.', 'detailedDescription': 'To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.\n\nTherefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.\n\nThe finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.\n\nPatients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.\n\nThe subjects will be randomly assigned into one of three groups:\n\n* Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.\n* Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.\n* Group III (control) will receive traditional chest physiotherapy only. The measures will be taken before and after treatment program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodynamic stable (MAP not less than 60mmHg, systolic pressure \\>80mmHg and diastolic pressure not \\<60mmHg)\n* Age from 40 to 85 years.\n* Both sexes.\n* All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.\n* All patients suffer from respiratory complications.\n* All patients included are actively breathing.\n* All patients included are fully aware and conscious.\n\nExclusion Criteria:\n\n* Hemodynamic Instability.\n* Severe Head Injury.\n* Increased intracranial pressure.\n* Anemic Hb\\<8.\n* Active Smoking.\n* Severe Bronchospasm.\n* Low BP (systole \\<80, diastole \\<60).\n* Subcutaneous Emphysema.\n* Rip Fractures.\n* Untreated Pneumothorax.'}, 'identificationModule': {'nctId': 'NCT06191367', 'briefTitle': 'Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients', 'orgStudyIdInfo': {'id': 'CairoU post-covid PF Rehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.', 'description': 'It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months).', 'interventionNames': ['Other: Aerobic Exercises', 'Other: Traditional Chest Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.', 'description': 'It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months).', 'interventionNames': ['Device: Incentive Spirometer Device', 'Other: Traditional Chest Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (control) will receive Traditional Chest Physiotherapy only.', 'description': 'As a control group it was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received traditional program of chest physiotherapy only. (Five times per week for two months).\n\nfor example: - Breathing Exercises. - Postural Drainage. - Percussion. - Coughing - Vibration.', 'interventionNames': ['Other: Traditional Chest Physiotherapy']}], 'interventions': [{'name': 'Aerobic Exercises', 'type': 'OTHER', 'description': 'Aerobic Exercises', 'armGroupLabels': ['Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.']}, {'name': 'Incentive Spirometer Device', 'type': 'DEVICE', 'description': 'is a handheld medical device used to help patients improve the functioning of their lungs. By training patients to take slow and deep breaths, this simplified spirometer facilitates lung expansion and strengthening. Patients inhale through a mouthpiece, which causes a piston inside the device to rise. This visual feedback helps them monitor their inspiratory effort. Incentive spirometers are commonly used after surgery or other illnesses to prevent pulmonary complications.', 'armGroupLabels': ['Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.']}, {'name': 'Traditional Chest Physiotherapy', 'type': 'OTHER', 'description': '1. Breathing exercise.\n2. Postural drainage.\n3. Percussion.\n4. Coughing.\n5. Vibration.', 'armGroupLabels': ['Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.', 'Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.', 'Group III (control) will receive Traditional Chest Physiotherapy only.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Physiotherapy department Police Academy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed H Elgendy, Doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physiotherapy Faculty, Cairo University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McCarious Nahad Aziz Abdelshaheed Stephens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'McCarious Nahad Aziz Abdelshaheed Stephens', 'investigatorAffiliation': 'Cairo University'}}}}