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

Not Applicable

Recruiting

• Conditions: Asthma
• Interventions: Other: Bubble Positive Expiratory Pressure Device; Other: Active Cycle Breathing Technique

• Registration Number: NCT06176742
• Lead Sponsor: Riphah International University

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.

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 Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-10-26
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bubble Positive Expiratory Pressure Device	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.
Active Cycle Breathing Technique	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.

Primary Outcome Measures

Name	Time	Method
Dyspnea 12 Tool	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.
Breathlessness, Cough, and Sputum Scale (BCSS)	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.
Pulmonary Function Test	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.

Trial Locations

Locations (1)

DHQ Hospital; 🇵🇰 Muzaffargarh, Punjab, Pakistan