Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-02 @ 2:12 AM
Study NCT ID:
NCT06476769
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015916', 'term': 'Drainage, Postural'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breathlessness cough sputum scale', 'timeFrame': '4 weeks', 'description': 'Breathlessness, Cough and Sputum scale (BCSS) was developed to effectively measure the severity of respiratory symptoms. The BCSS records symptoms in a 5-point Likert like scale in which zero represents improvement symptoms and scores towards 4 indicating worsening of symptoms. It is commonly used in patients with COPD. BCSS provides a simple and robust quantification of symptoms that is sensitive to the effects of treatment and could therefore be used to assess therapeutic interventions. It has good reliability and validity for use in patients with respiratory disorders.'}, {'measure': 'Modified borg RPE scale:', 'timeFrame': '4 weeks', 'description': 'The Modified Borg Dyspnea Scale (MBS) is rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise, one of the most common and frequently used measures to assess the severity of dyspnea.'}, {'measure': 'Incentive spirometry', 'timeFrame': '4 weeks', 'description': 'Incentive spirometry is frequently used after thoracic surgery as an adjunct to physiotherapy. Despite its widespread use, it has remained challenging to demonstrate a clinical benefit in terms of either incidence of pulmonary complications or hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyspnea', 'Postural drainage'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '16891108', 'type': 'BACKGROUND', 'citation': 'Kullowatz A, Kanniess F, Dahme B, Magnussen H, Ritz T. Association of depression and anxiety with health care use and quality of life in asthma patients. Respir Med. 2007 Mar;101(3):638-44. doi: 10.1016/j.rmed.2006.06.002. Epub 2006 Aug 7.'}, {'pmid': '12877402', 'type': 'BACKGROUND', 'citation': 'Goodwin RD, Eaton WW. Asthma and the risk of panic attacks among adults in the community. Psychol Med. 2003 Jul;33(5):879-85. doi: 10.1017/s0033291703007633.'}, {'pmid': '10195081', 'type': 'BACKGROUND', 'citation': 'Wright RJ, Rodriguez M, Cohen S. Review of psychosocial stress and asthma: an integrated biopsychosocial approach. Thorax. 1998 Dec;53(12):1066-74. doi: 10.1136/thx.53.12.1066.'}]}, 'descriptionModule': {'briefSummary': 'It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed moderate to severe GOLD (2017) COPD\n* 40-60 years old\n* Both male and female\n* Patients hemodynamically stable\n* PFT showing irreversible airflow limitation.\n\nExclusion Criteria:\n\n* Type II diabetic mellitus\n* Systemic illness\n* Thoracic deformation or rib fracture.\n* Pulmonale decompensation and signs of an unstable heart condition.'}, 'identificationModule': {'nctId': 'NCT06476769', 'briefTitle': 'Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/23/0376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blow bottle technique', 'description': 'There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.', 'interventionNames': ['Other: blow bottle technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'percussion', 'description': 'There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.', 'interventionNames': ['Other: percussion']}], 'interventions': [{'name': 'blow bottle technique', 'type': 'OTHER', 'otherNames': ['postural drainage'], 'description': 'There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.', 'armGroupLabels': ['blow bottle technique']}, {'name': 'percussion', 'type': 'OTHER', 'otherNames': ['postural drainage'], 'description': 'Group B: There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.', 'armGroupLabels': ['percussion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sidra Faisal, MS.CPPT', 'role': 'CONTACT', 'email': 'sidra.faisal@riphah.edu.pk', 'phone': '03022001847'}], 'facility': 'Wazirabad Institute of Cardiology', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}], 'centralContacts': [{'name': 'Iqbal Tariq, PHD', 'role': 'CONTACT', 'email': 'iqbal.tariq@riphah.edu.pk', 'phone': 'O3338236752'}, {'name': 'imran amjad, PHD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Sidra Faisal, MS.CPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}