Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-28 @ 9:43 PM
Study NCT ID:
NCT06047795
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2023-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endurance Training in Patients With Post-TB Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.'}, {'measure': 'Dyspnea', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through the BORG dyspnea scale. it uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea.'}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '3 weeks,6 weeks', 'description': 'Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters'}, {'measure': 'Forced vital Capacity (FVC)', 'timeFrame': '3 weeks,6 weeks', 'description': 'Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': '3 weeks,6 weeks', 'description': 'Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endurance training', 'Functional Capacity', 'Post-TB lung disease', 'Quality of Life'], 'conditions': ['Tuberculosis', 'Post-Tuberculous Pleural Fibrosis', 'Post-Tuberculous Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.', 'detailedDescription': 'Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TB (diagnosed) with Completed TB course\n* Dyspnea (with or without cough)\n* Age (18-50yrs).\n* After 3 months of AFB and gene expert (-)\n* Decreased PFT predicted values\n\nExclusion Criteria:\n\n* Smoker, Diabetes, and cardiac patients\n* Physical disabled, pregnant (lactating women)\n* Sputum + testing for TB\n* Gene expert\n* CVD (unstable)\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT06047795', 'briefTitle': 'Endurance Training in Patients With Post-TB Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease', 'orgStudyIdInfo': {'id': 'Rec/01657 Safa Marwa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Aerobic and respiratory endurance exercises with patient education', 'interventionNames': ['Other: Experimental']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Usual care (Patient Education, Home Plan)', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Cycling 2 days per week with Borg dyspnea 4-6 level for 15-20 minutes/ day with 5 minutes warm-up and cool-down.\n\nStrengthening exercises for upper limb muscles (pull-ups and biceps curls) and for lower limb muscles (sit-to-stand and step-up exercises) with 3 sets of 8-12 repetitions \\* 2 days per week.\n\nPursed Lip breathing exercise 3 sets of 5-10 repetitions for 6 weeks', 'armGroupLabels': ['Interventional']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Usual care: frontal chest radiographs, verbal advice to quit smoking, and reduce exposure to biomass smoke.\n\nSpirometry to screen for airway diseases. Antibiotic and systemic glucocorticoid therapy.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Green Star NGO', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Mehwish Waseem, MSPT-CPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}