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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05026918
Other study ID # REC/Lhr/0332 Hafsa Javed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date July 20, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 20, 2021
Est. primary completion date July 4, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 25 Years
Eligibility Inclusion Criteria: - Age limit 5-25 - Patients with confirmed diagnosis of Cystic Fibrosis - Male and female. - Clinically Stable Patients Exclusion Criteria: - Hypertensive patients. - Intolerant patients. - Compromised Renal Function. - Other Comorbidities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MCPT
Postural Drainagewith percussion and vibration
ACBT
ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique

Locations

Country Name City State
Pakistan PAF Hospital Islamabad Capital

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2013;9:CD001401. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Borg dyspnea Scale 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). 2nd week
Primary Quality of well-being Scale 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 2nd week
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