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Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
MCPT
ACBT
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PAF Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
August 27, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05026918
Brief Title
Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
Official Title
A Comparison Between the Effectiveness of Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
July 4, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm 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.
Arm Title
Group B
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
MCPT
Intervention Description
Postural Drainagewith percussion and vibration
Intervention Type
Other
Intervention Name(s)
ACBT
Intervention Description
ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique
Primary Outcome Measure Information:
Title
Modified Borg dyspnea Scale
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).
Time Frame
2nd week
Title
Quality of well-being Scale
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
Time Frame
2nd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAF Hospital
City
Islamabad
State/Province
Capital
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33792230
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.
Results Reference
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PubMed Identifier
10796781
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.
Results Reference
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PubMed Identifier
3171787
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.
Results Reference
background
PubMed Identifier
27086904
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.
Results Reference
background
PubMed Identifier
25225791
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.
Results Reference
background
PubMed Identifier
16412951
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.
Results Reference
background
PubMed Identifier
11722291
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.
Results Reference
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PubMed Identifier
7988215
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.
Results Reference
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Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis

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