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

NCT06176742 | Unknown

• 1 other identifier: REC/RCR & AHS/23/0330
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Asthma; Active Cycle Breathing Technique; Bubble PEP

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Bubble Positive Expiratory Pressure Device

EXPERIMENTAL

Diaphragmatic breathing technique will be the baseline treatment. B group will be treated with bubble positive expiratory pressure device. Patients will be encouraged to blow down the tubing into the water, and make bubbles. This creates positive pressure back up the tubing and into patient's airways and lungs. As the pressure holds open your patient's airways, it helps more air to move in and out of their lungs. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.

Other: Bubble Positive Expiratory Pressure Device

Active Cycle Breathing Technique

ACTIVE COMPARATOR

Diaphragmatic breathing technique will be the baseline treatment.A group will be treated with active cycle breathing technique. The technique consists of inspiratory hold technique, deep breathing and forced expiration. These are repeated in a cycle until your chest feels clear. You can carry out ACBT when either sitting or lying down. Physiotherapist will discuss this with you during your physiotherapy assessment. All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.

Other: Active Cycle Breathing Technique

Interventions

Active Cycle Breathing Technique OTHER

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.

Active Cycle Breathing Technique

Bubble Positive Expiratory Pressure Device OTHER

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.

Bubble Positive Expiratory Pressure Device

Eligibility Criteria

• Age: 31 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with hypertension
• Cardiac diseases
• Any rib fracture
• Previously taken instructions regarding this.
• Any other unstable medical conditions

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital

Muzaffargarh, Punjab Province, 34200, Pakistan

RECRUITING

Related Publications (15)

• 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.

  PMID: 32113192 BACKGROUND

• 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.

  PMID: 36698169 BACKGROUND

• 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.

  PMID: 19327187 BACKGROUND

• 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.

  PMID: 17650355 BACKGROUND

• 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.

  PMID: 22100537 BACKGROUND

• 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.

  PMID: 25705944 BACKGROUND

• 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.

  PMID: 17416409 BACKGROUND

• 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.

  PMID: 20926125 BACKGROUND

• 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.

  PMID: 16935691 BACKGROUND

• 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.

  PMID: 22436168 BACKGROUND

• 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.

  PMID: 18763028 BACKGROUND

• 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.

  PMID: 17298337 BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• 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-

  BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Arnab Altaf

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: December 20, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)