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

NCT05026918 | Completed DMC

• 1 other identifier: REC/Lhr/0332 Hafsa Javed
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Other: MCPT

Group B

EXPERIMENTAL

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.

Other: ACBT

Interventions

MCPT OTHER

Postural Drainagewith percussion and vibration

Group A

ACBT OTHER

ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique

Group B

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age limit 5-25
• Patients with confirmed diagnosis of Cystic Fibrosis
• Male and female.
• Clinically Stable Patients

You may not qualify if:

• Hypertensive patients.
• Intolerant patients.
• Compromised Renal Function.
• Other Comorbidities

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

PAF Hospital

Islamabad, Capital, Pakistan

Location

Related Publications (8)

• 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: 33792230 BACKGROUND

• 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: 10796781 BACKGROUND

• 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: 3171787 BACKGROUND

• 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: 27086904 BACKGROUND

• 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: 25225791 BACKGROUND

• 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: 16412951 BACKGROUND

• 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: 11722291 BACKGROUND

• 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.

  PMID: 7988215 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

S-(N-monomethoxytritylaminoethyl)-O-(2-chlorophenyl)phosphorothioate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Fareeha Kausar, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: August 30, 2021
• Study Start: October 13, 2020
• Primary Completion: July 4, 2021
• Study Completion: July 20, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)