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

NCT07062939 | Not Yet Recruiting

• 1 other identifier: REC/RCR & AHS/24/0350
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

postural drainage; flutter; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

• The Pittsburgh Sleep Quality Index (PSQI)

  This is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval, show the sleep quality duration and efficacy. Many of the aforementioned research employed the PSQI, the most commonly utilized sleep quality index. the validity and reliability of the PSQI in healthcare professionals, or even in high-pressure shift employees. The PSQI's validity and reliability in regularly planned, low-pressure groups, such as adults in good health who live in the vicinity, differed greatly from front-line COVID-19 healthcare personnel. The conventional test theory (CTT) serves as the primary foundation for the reliability and validity research on PSQI. While there is little to no link between the PSQI and problems including anger, nausea,stiffness, and urinary disorder, it does have a strong correlation with the Insomnia Severity Index, polysomnography, and other sleep quality indicators

  4 weeks

• The Shwachman-Kulczycki score

  This is the first scoring system used in cystic fibrosis to assess disease severity and show the adherence to treatment. In the present study, the total Shwachman-Kulczycki score correlated positively with the scores for each of its four domains, and physical activity was the aspect that most influenced total score.

  4 weeks

• Borg dyspnea scale

  The instruments provide a standard method for patients to select ratings of dyspnea on a scale based on descriptors that correspond to specific numbers

  4 weeks

Secondary Outcomes (1)

• The Breathlessness, Cough and Sputum Scale (BCSS)

  4 weeks

Study Arms (2)

postural drainage with ACBT

EXPERIMENTAL

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

Other: postural drainage with ACBT

flutter with ACBT

ACTIVE COMPARATOR

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

Other: flutter with ACBT

Interventions

postural drainage with ACBT OTHER

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

postural drainage with ACBT

flutter with ACBT OTHER

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

flutter with ACBT

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital

Sheikhupura, Punjab Province, 39350, Pakistan

Location

Related Publications (6)

• Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.

  PMID: 35235877 BACKGROUND

• 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.

  PMID: 34557648 BACKGROUND

• 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.

  PMID: 27298017 BACKGROUND

• 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.

  PMID: 36727723 BACKGROUND

• 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.

  PMID: 31740105 BACKGROUND

• 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.

  PMID: 36568612 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Drainage, Postural

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

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy

Study Officials

• iram nawaz, mphill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phD

CONTACT

03324390125; imran.amjad@riphah.du.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 6, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)