Comparative Effects of ACBT and Bubble Positive Expiratory Pressure Device in Asthmatic Patients

Asthma Clinical Trial

Official title:

Comparative Effects of Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in Asthmatic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176742
• Other study ID #: REC/RCR & AHS/23/0330
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study gap is that in previous studies the effects of bubble-PEP in different diseases have been studied but it's never been studied in asthmatic patients, so the reason behind this study is to see effects of bubble-PEP in Asthmatic Patients.

Description:

The aim of this study was to determine the effect of Bubble-PEP device compared to ACBT in asthmatic patients. This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT and group B will be treated with bubble-PEP device. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 40 Years

Eligibility

Inclusion Criteria:

• Aged between 31 to 40 years

• Male & Female

• Mild Asthmatic Patients

• Able to perform techniques

• Those who have never taken therapies for asthma before.

• Chronic Asthma

Exclusion Criteria:

• Patients with hypertension

• Cardiac diseases

• Any rib fracture

• Previously taken instructions regarding this.

• Any other unstable medical conditions

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Active Cycle Breathing Technique
This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25.
• Bubble Positive Expiratory Pressure Device
This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group B will be treated with bubble-PEP. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25.

Locations

Country	Name	City	State
Pakistan	DHQ Hospital	Muzaffargarh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

Bousquet J, Dahl R, Khaltaev N. Global alliance against chronic respiratory diseases. Allergy. 2007 Mar;62(3):216-23. doi: 10.1111/j.1398-9995.2007.01307.x. — View Citation

Bousquet J, Mantzouranis E, Cruz AA, Ait-Khaled N, Baena-Cagnani CE, Bleecker ER, Brightling CE, Burney P, Bush A, Busse WW, Casale TB, Chan-Yeung M, Chen R, Chowdhury B, Chung KF, Dahl R, Drazen JM, Fabbri LM, Holgate ST, Kauffmann F, Haahtela T, Khaltaev N, Kiley JP, Masjedi MR, Mohammad Y, O'Byrne P, Partridge MR, Rabe KF, Togias A, van Weel C, Wenzel S, Zhong N, Zuberbier T. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol. 2010 Nov;126(5):926-38. doi: 10.1016/j.jaci.2010.07.019. — View Citation

Chanez P, Wenzel SE, Anderson GP, Anto JM, Bel EH, Boulet LP, Brightling CE, Busse WW, Castro M, Dahlen B, Dahlen SE, Fabbri LM, Holgate ST, Humbert M, Gaga M, Joos GF, Levy B, Rabe KF, Sterk PJ, Wilson SJ, Vachier I. Severe asthma in adults: what are the important questions? J Allergy Clin Immunol. 2007 Jun;119(6):1337-48. doi: 10.1016/j.jaci.2006.11.702. Epub 2007 Apr 9. — View Citation

Eastwood B, Jepsen N, Coulter K, Wong C, Zeng I. Challenges of undertaking a clinical trial using bubble-PEP in an acute exacerbation of chronic obstructive pulmonary disease: A feasibility study. New Zealand Journal of Physiotherapy. 2016 Mar 1;44(1).

Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18. — View Citation

Mahdaviani SA, Rezaei N, Moradi B, Dorkhosh S, Amirzargar AA, Movahedi M. Proinflammatory cytokine gene polymorphisms among Iranian patients with asthma. J Clin Immunol. 2009 Jan;29(1):57-62. doi: 10.1007/s10875-008-9232-1. Epub 2008 Sep 2. — View Citation

McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3. — View Citation

Mestriner RG, Fernandes RO, Steffen LC, Donadio MV. Optimum design parameters for a therapist-constructed positive-expiratory-pressure therapy bottle device. Respir Care. 2009 Apr;54(4):504-8. — View Citation

Murphy AC, Proeschal A, Brightling CE, Wardlaw AJ, Pavord I, Bradding P, Green RH. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Thorax. 2012 Aug;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096. Epub 2012 Mar 21. — View Citation

Phillips J, Hing W, Pope R, Canov A, Harley N, Lee AL. Active cycle of breathing technique versus oscillating PEP therapy versus walking with huffing during an acute exacerbation of bronchiectasis: a randomised, controlled trial protocol. BMC Pulm Med. 2023 Jan 25;23(1):36. doi: 10.1186/s12890-023-02324-8. — View Citation

Santos MD, Milross MA, McKenzie DK, Alison JA. Bubble-positive expiratory pressure device and sputum clearance in bronchiectasis: A randomised cross-over study. Physiother Res Int. 2020 Jul;25(3):e1836. doi: 10.1002/pri.1836. Epub 2020 Feb 29. — View Citation

Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5. — View Citation

Sundus S, Memoona S, Muhammad IN, Rashid HN. Effect of Active Cycle of Breathing Technique in Adult Asthmatic Patients in Pakistan. Asian Journal of Medicine and Biomedicine. 2017 Dec 21;1(1):32-

Wenzel SE. Asthma: defining of the persistent adult phenotypes. Lancet. 2006 Aug 26;368(9537):804-13. doi: 10.1016/S0140-6736(06)69290-8. — View Citation

Zuriati Z, Surya M. Effectiveness Active Cycle of Breathing Technique (ACBT) with Pursed Lips Breathing Technique (PLBT) to tripod position in increase oxygen saturation in patients with COPD, West Sumatera. Enfermeria Clinica. 2020 Jun 1;30:164-7.

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea 12 Tool	Dyspnea 12 is a valid and reliable measure of breathlessness in patients. It measures the current level of a patients breathlessness severity, incorporating both physical and affective aspects and does not depend on activity limitation. D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. The time reference period captures the current level of breathlessness experienced by patients as opposed to specifically on the day of the test or in response to a specific activity. Data will be calculated before and after treatment with the help of outcome measure tools.	Up to 24 weeks
Primary	Breathlessness, Cough, and Sputum Scale (BCSS)	The breathlessness, cough and sputum scale (BCSS) is used to predict patient exacerbation by evaluating common symptoms. The BCSS tool measures the patients self reported symptoms in real time. BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; from 0 to 4 the higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Data will be calculated before and after treatment with the help of outcome measure tools.	Upto 24 weeks
Primary	Pulmonary Function Test	Pulmonary function tests measure how much air you can exhale, and how quickly. There are several types of pulmonary function graphs that show data from the tests. The test which will be used is FEV1/FVC. This is the amount of air exhaled in the first second, compared with the total amount of air exhaled. It's given as a fraction (ratio) or a percentage. In general, the higher the FEV1/FVC, the better. This test will be done using Spirometer. Data will be calculated before and after treatment with the help of outcome measure tools.	Upto 24 weeks