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

December 19, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Muzaffargarh, Punjab, Pakistan, 34200
        • Recruiting
        • DHQ Hospital
        • Contact:
          • Arnab Altaf
          • Phone Number: 03064585776
        • Principal Investigator:
          • Muhammad Talha Javed, MSCPPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bubble Positive Expiratory Pressure Device
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
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.
Active Comparator: Active Cycle Breathing Technique

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea 12 Tool
Time Frame: Up to 24 weeks
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)
Time Frame: Upto 24 weeks
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
Time Frame: Upto 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Arnab Altaf, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Estimated)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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