- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026918
Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
August 27, 2021 updated by: Riphah International University
A Comparison Between the Effectiveness of Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Capital
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Islamabad, Capital, Pakistan
- PAF Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group A
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.
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Postural Drainagewith percussion and vibration
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Experimental: Group B
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.
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ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Borg dyspnea Scale
Time Frame: 2nd week
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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).
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2nd week
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Quality of well-being Scale
Time Frame: 2nd week
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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
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2nd week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fareeha Kausar, MSCPPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2020
Primary Completion (Actual)
July 4, 2021
Study Completion (Actual)
July 20, 2021
Study Registration Dates
First Submitted
August 27, 2021
First Submitted That Met QC Criteria
August 27, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/0332 Hafsa Javed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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