Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05026918
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058618', 'term': 'S-(N-monomethoxytritylaminoethyl)-O-(2-chlorophenyl)phosphorothioate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Borg dyspnea Scale', 'timeFrame': '2nd week', 'description': 'Modified Borg Dyspnea Scale is most commonly used to assess symptoms of breathlessness. It has a range from 0 to 10 (with 0 being no exertion and 10 being maximum effort).'}, {'measure': 'Quality of well-being Scale', 'timeFrame': '2nd week', 'description': 'The Quality of Well-Being Scale (QWB) is a general health quality of life questionnaire which measures overall status and well-being over the previous three days in four areas: physical activities, social activities, mobility, and symptom/problem complexes. It consists of 71 items and takes 20 minutes to complete'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '33792230', 'type': 'BACKGROUND', 'citation': 'Kalamara EI, Ballas ET, Pitsiou G, Petrova G. Pulmonary rehabilitation for cystic fibrosis: A narrative review of current literature. Monaldi Arch Chest Dis. 2021 Mar 11;91(2). doi: 10.4081/monaldi.2021.1501.'}, {'pmid': '10796781', 'type': 'BACKGROUND', 'citation': 'van der Schans C, Prasad A, Main E. Chest physiotherapy compared to no chest physiotherapy for cystic fibrosis. Cochrane Database Syst Rev. 2000;(2):CD001401. doi: 10.1002/14651858.CD001401.'}, {'pmid': '3171787', 'type': 'BACKGROUND', 'citation': 'Reisman JJ, Rivington-Law B, Corey M, Marcotte J, Wannamaker E, Harcourt D, Levison H. Role of conventional physiotherapy in cystic fibrosis. J Pediatr. 1988 Oct;113(4):632-6. doi: 10.1016/s0022-3476(88)80370-6.'}, {'pmid': '27086904', 'type': 'BACKGROUND', 'citation': "Button BM, Wilson C, Dentice R, Cox NS, Middleton A, Tannenbaum E, Bishop J, Cobb R, Burton K, Wood M, Moran F, Black R, Bowen S, Day R, Depiazzi J, Doiron K, Doumit M, Dwyer T, Elliot A, Fuller L, Hall K, Hutchins M, Kerr M, Lee AL, Mans C, O'Connor L, Steward R, Potter A, Rasekaba T, Scoones R, Tarrant B, Ward N, West S, White D, Wilson L, Wood J, Holland AE. Physiotherapy for cystic fibrosis in Australia and New Zealand: A clinical practice guideline. Respirology. 2016 May;21(4):656-67. doi: 10.1111/resp.12764. Epub 2016 Apr 18."}, {'pmid': '25225791', 'type': 'BACKGROUND', 'citation': 'McIlwaine MP, Lee Son NM, Richmond ML. Physiotherapy and cystic fibrosis: what is the evidence base? Curr Opin Pulm Med. 2014 Nov;20(6):613-7. doi: 10.1097/MCP.0000000000000110.'}, {'pmid': '16412951', 'type': 'BACKGROUND', 'citation': 'Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.'}, {'pmid': '11722291', 'type': 'BACKGROUND', 'citation': 'Williams MT, Parsons DW, Frick RA, Ellis ER, Martin AJ, Giles SE, Grant ER. Acute respiratory infection in patients with cystic fibrosis with mild pulmonary impairment: comparison of two physiotherapy regimens. Aust J Physiother. 2001;47(4):227-36. doi: 10.1016/s0004-9514(14)60270-1.'}, {'pmid': '7988215', 'type': 'BACKGROUND', 'citation': 'Williams MT. Chest physiotherapy and cystic fibrosis. Why is the most effective form of treatment still unclear? Chest. 1994 Dec;106(6):1872-82. doi: 10.1378/chest.106.6.1872. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis is a genetic disease (autosomal recessive) which involves malfunction of the exocrine glands, leading to abnormal secretions in the body. It is a progressive disease that causes persistent lung infections and limits the ability to breathe over time. Clinical symptoms include persistent coughing, at times with phlegm, wheezing or shortness of breath, fatigue, difficulty with bowel movements sinus infections, poor growth, clubbing of the fingers and toes, and infertility in most males. The disease must be managed throughout life with diet, medication and preventive chest physical therapy as soon as any symptoms are noted in the young child. The purpose of the study was to evaluate the difference between the effects of Manual Chest Physiotherapy (CPT) and Active Cycle of Breathing Techniques (ACBT) in patients of Cystic Fibrosis. The tools of our study were Modified Borg Dyspnea Scale and Quality of well-being Scale. The total sample of our study was 14 out of which 7 were included in GROUP A and 7 Group B. SPSS 23 was used for statistical analysis and parametric tests were used for analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age limit 5-25\n* Patients with confirmed diagnosis of Cystic Fibrosis\n* Male and female.\n* Clinically Stable Patients\n\nExclusion Criteria:\n\n* Hypertensive patients.\n* Intolerant patients.\n* Compromised Renal Function.\n* Other Comorbidities'}, 'identificationModule': {'nctId': 'NCT05026918', 'briefTitle': 'Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'A Comparison Between the Effectiveness of Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'REC/Lhr/0332 Hafsa Javed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': "all the components of Manual Chest Physiotherapy wer performed on the patients of this group. MCPT was done few hours before meals and it was made sure that nothing was in patient's mouth while doing chest physiotherapy. MCPT includes postural drainage, percussion and vibrations. Chest Physiotherapy was done thrice a day for 30 minutes and there were 21 sessions a week.", 'interventionNames': ['Other: MCPT']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'all the components of Active Cycle of Breathing techniques (ACBT) were performed on the patients of this group. ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique. These were performed thrice a day for 30 minutes and for 21 sessions a week.', 'interventionNames': ['Other: ACBT']}], 'interventions': [{'name': 'MCPT', 'type': 'OTHER', 'description': 'Postural Drainagewith percussion and vibration', 'armGroupLabels': ['Group A']}, {'name': 'ACBT', 'type': 'OTHER', 'description': 'ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'state': 'Capital', 'country': 'Pakistan', 'facility': 'PAF Hospital', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Fareeha Kausar, MSCPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}