Cystic FibrosisNCT07062939
Comparative Effects of Mechanical and Manual Airway Clearance Techniques in Cystic Fibrosis
A study testing postural drainage with ACBT and flutter with ACBT in people with Cystic Fibrosis, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- postural drainage with ACBT and flutter with ACBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient having clinically diagnose Cystic fibrosis.
- Age 16-40 year.
- Both male and female.
- Subjects who are conscious and cooperative .
Who cannot join
- Rib fracture
- History of cardiac surgery.
- Subject with any Physical or Mental Disability
- Age less than 16 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
DHQ Hospital
Sheikhupura, Punjab Province, 39350
Iram Nawaz, mphill, 03324645227, iram_029@yahoo.com
Fibha sherwani, MSCPPT
About this study
Official title: Comparative Effects of Manual Versus Mechanical Airway Clearance Techniques in Cystic Fibrosis
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.
Read the 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
- Being tested
- postural drainage with ACBT, flutter with ACBT
- Keywords
- postural drainage, flutter, pulmonary rehabilitation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural drainage with ACBTOther
postural drainage and ACBT for 2 times a day for 30 min for 4 weeks.
flutter with ACBTOther
flutter with active cycle breathing technique for 30 min. for 4 week and 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| postural drainage with ACBT | Experimental | postural drainage and active cycle breathing technique for 2 times a day for 30 min for 4 weeks Receives: 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 Receives: Other: flutter with ACBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 4 weeks
Secondary outcomes (1)
The Breathlessness, Cough and Sputum Scale (BCSS)
This scale is used to predict patient exacerbations by evaluating common symptoms, Results suggest BCSS scores are valid indicators of the severity of cough and sputum in patients with COPD. Scores for both items were correlated with sputum volume.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start6 Jul 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- iram nawaz, mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062939
- Sponsor's protocol ID
- REC/RCR & AHS/24/0350
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35235877Chen 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.
PubMed 34557648Elborn 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.
PubMed 27298017Wilson 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.
PubMed 36727723Rowbotham 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.
PubMed 31740105Zhao 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.
PubMed 36568612
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Versus Mechanical Airway Clearance Techniques in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT07062939
- Acronym / sponsor ID
- REC/RCR & AHS/24/0350
- Conditions
- Cystic Fibrosis
- Keywords
- postural drainage, flutter, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 Jul 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postural drainage with ACBT | Experimental | Other: postural drainage with ACBTpostural drainage and active cycle breathing technique for 2 times a day for 30 min for 4 weeks |
| flutter with ACBT | Active comparator | Other: flutter with ACBTactive cycle breathing technique with flutter for 30 min for 4 week and 2 times a day |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient having clinically diagnose Cystic fibrosis.
- Age 16-40 year.
- Both male and female.
- Subjects who are conscious and cooperative .
Key exclusion criteria (4 listed)
- Rib fracture
- History of cardiac surgery.
- Subject with any Physical or Mental Disability
- Age less than 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postural drainage with ACBTpostural drainage and ACBT for 2 times a day for 30 min for 4 weeks. | Other | postural drainage with ACBT |
| flutter with ACBTflutter with active cycle breathing technique for 30 min. for 4 week and 2 times a day. | Other | flutter with ACBT |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
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
The Shwachman-Kulczycki score
Time frame: 4 weeks
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.
Borg dyspnea scale
Time frame: 4 weeks
The instruments provide a standard method for patients to select ratings of dyspnea on a scale based on descriptors that correspond to specific numbers
1 secondary outcome
The Breathlessness, Cough and Sputum Scale (BCSS)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 35235877Zisi 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.
- Background: PubMed 34557648Chen 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.
- Background: PubMed 27298017Elborn 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.
- Background: PubMed 36727723Wilson 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.
- Background: PubMed 31740105Rowbotham 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.
- Background: PubMed 36568612Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
iram nawaz, mphill principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postural drainage with ACBT and flutter with ACBT in people with Cystic Fibrosis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phD (03324390125, imran.amjad@riphah.du.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index (PSQI) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062939, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.