Comparative Effects of Mechanical and Manual Airway Clearance Techniques in Cystic Fibrosis

NCT ID: NCT07062939

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-06
• Study Completion Date: 2025-12-30

Brief Summary

This study will help to establish evidence-based physiotherapy on postural drainage and ACBT against flutter with ACBT is better to improve sleep quality, adherence, dyspnea in patients with cystic fibrosis and which method can improve respiratory function, reduce the risk of complications after illness and additionally advancements in respiratory therapy can lead to improve sleep quality, individual preference and adherence and dyspnea.

Detailed Description

Cystic fibrosis (CF) is a genetic disorder that leads to the accumulation of thick mucus in the lungs and other organs, resulting in recurrent infections and progressive lung damage. This condition is due to mutations in the cystic fibrosis transmembrane conductance regulator CFTR gene, which governs the transport of chloride and other ions across cell membranes. CF affects a significant number of people worldwide, with certain genetic mutations leading to more severe manifestations of the disease. The management of CF is centered on clearing the airways of mucus to prevent infections and slow the progression of lung damage. Various studies have yielded inconsistent results regarding the comparative effectiveness of manual versus mechanical airway clearance techniques in improving pulmonary function tests (PFTs) in CF patients.

Despite the existing literature on postural drainage with ACBT in patient with cystic fibrosis, there is a significant research gap regarding the flutter and ACBT on the bases of outcomes in cystic fibrosis. Most studies have not adequately addressed the distinct needs and responses of flutter with ACBT on the basis of outcomes, leaving a void in understanding how these two intervention effect on sleep, adherence and dyspnea in the context of patients with cystic fibrosis. Closing this gap is essential for developing evidence-based and pulmonary rehabilitation techniques for this specific patient group.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

postural drainage with ACBT

postural drainage and active cycle breathing technique for 2 times a day for 30 min for 4 weeks

Group Type: EXPERIMENTAL

postural drainage with ACBT

Intervention Type: OTHER

postural drainage and ACBT for 2 times a day for 30 min for 4 weeks.

flutter with ACBT

active cycle breathing technique with flutter for 30 min for 4 week and 2 times a day

Group Type: ACTIVE_COMPARATOR

flutter with ACBT

Intervention Type: OTHER

flutter with active cycle breathing technique for 30 min. for 4 week and 2 times a day.

Interventions

postural drainage with ACBT

postural drainage and ACBT for 2 times a day for 30 min for 4 weeks.

Intervention Type: OTHER

flutter with ACBT

flutter with active cycle breathing technique for 30 min. for 4 week and 2 times a day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient having clinically diagnose Cystic fibrosis.
• Age 16-40 year.
• Both male and female.
• Subjects who are conscious and cooperative .

Exclusion Criteria

• Rib fracture
• History of cardiac surgery.
• Subject with any Physical or Mental Disability
• Age less than 16 years

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

iram nawaz, mphill

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Hospital

Sheikhupura, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

imran amjad, phD

Role: CONTACT

imran.amjad@riphah.du.pk

03324390125

Facility Contacts

Iram Nawaz, mphill

Role: primary

iram_029@yahoo.com

03324645227

References

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Reference Type: BACKGROUND

PMID: 35235877 (View on PubMed)

Chen Q, Shen Y, Zheng J. A review of cystic fibrosis: Basic and clinical aspects. Animal Model Exp Med. 2021 Sep 16;4(3):220-232. doi: 10.1002/ame2.12180. eCollection 2021 Sep.

Reference Type: BACKGROUND

PMID: 34557648 (View on PubMed)

Elborn JS, Ramsey BW, Boyle MP, Konstan MW, Huang X, Marigowda G, Waltz D, Wainwright CE; VX-809 TRAFFIC and TRANSPORT study groups. Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis. Lancet Respir Med. 2016 Aug;4(8):617-626. doi: 10.1016/S2213-2600(16)30121-7. Epub 2016 Jun 10.

Reference Type: BACKGROUND

PMID: 27298017 (View on PubMed)

Wilson LM, Saldanha IJ, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2023 Feb 2;2(2):CD007862. doi: 10.1002/14651858.CD007862.pub5.

Reference Type: BACKGROUND

PMID: 36727723 (View on PubMed)

Rowbotham NJ, Smith SJ, Davies G, Daniels T, Elliott ZC, Gathercole K, Rayner OC, Smyth AR. Can exercise replace airway clearance techniques in cystic fibrosis? A survey of patients and healthcare professionals. J Cyst Fibros. 2020 Jul;19(4):e19-e24. doi: 10.1016/j.jcf.2019.10.026. Epub 2019 Nov 15.

Reference Type: BACKGROUND

PMID: 31740105 (View on PubMed)

Zhao M, Cheng L, Fu W, Ma X, Chen X. Measuring parents' perceptions of inclusive school quality in China: the development of the PISQ scale. Int J Dev Disabil. 2021 Mar 10;68(6):824-837. doi: 10.1080/20473869.2021.1895696. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36568612 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0350

Identifier Type: -

Identifier Source: org_study_id