- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922267
Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease
Comparative Effects of Active Cycle of Breathing Techniques and Slow Expiration With Open Glottis in Lateral Posture in Patients With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life .Therefore, Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable for every patient to reduce condition . The effect of ELTGOL on mucus clearance of right and left lungs, especially of peripheral lung areas, in stable patients with COPD . A couple of relaxed breaths and when you are ready go on to your huff. Repeat the huff two or three times until you have the urge to cough. Once you have cleared your chest have a few normal relaxed breaths and start the cycle over again with deep breaths and huffs.
A Randomized clinical trial, subjects with age group between 4O-70 years. In Group -A subjects (n=15) were treated with Active Cycle of Breathing Technique where Group-B subjects (n=15) received ELTGOL training . This study is to compare the effectiveness of ACBT and ELTGOL on improving the Quality Of Life and increasing Functional Capacity in subjects with COPD . Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Mayo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders (Male and Female)
- 40-70 years
- Diagnosed COPD according to GOLD classification
- Hemodynamically stable patient
Exclusion Criteria:
- Patient with other disorders like cardiac and respiratory disorders
- Carcinoma
- Lung surgery
- Neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active cycle of breathing technique
Try to keep your chest
|
The participants in group A will be given ACBT with conventional chest physiotherapy . Instruction for patient
|
|
Experimental: SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
The participants in group B will be given slow expiration with open glottis in lateral posture and conventional chest physiotherapy .In this technique, a patient adopts a lateral posture or a lateral decubitus posture.
The affected lung is in the dependent position.
A patient commences breathing normally, at tidal volumes.
They are then instructed to perform a series of slow expirations with an open glottis.
Expiration from functional residual capacity to the end of the expiratory reserve volume are encouraged to achieve maximum inflation .
To assist in maintaining an open glottis, a mouthpiece may be used, to decrease the degree of airway compression A series of three ELTGOL may be performed, with each series composed of approximately 10 slow and deep expirations.
In between each series of maneuvers, a rest period (around 1-2 minutes) is provided, with the patient staying in the same position.
A typical treatment lasts for around 20 minutes
|
The participants in group B will be given slow expiration with open glottis in lateral posture and conventional chest physiotherapy .In this technique, a patient adopts a lateral posture or a lateral decubitus posture.
The affected lung is in the dependent position.
A patient commences breathing normally, at tidal volumes.
They are then instructed to perform a series of slow expirations with an open glottis.
Expiration from functional residual capacity to the end of the expiratory reserve volume are encouraged to achieve maximum inflation .
To assist in maintaining an open glottis, a mouthpiece may be used, to decrease the degree of airway compression A series of three ELTGOL may be performed, with each series composed of approximately 10 slow and deep expirations.
In between each series of maneuvers, a rest period (around 1-2 minutes) is provided, with the patient staying in the same position.
A typical treatment lasts for around 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea scale to assess change in pre and post
Time Frame: base line and fourth week
|
Medical Research Council (MRC) chronic dyspnea scale, used for the estimation of disability due to dyspnea, may serve as a simple index of disease severity and extent in patients with lung disease.
This scale consists of six questions about perceived breathlessness: category 0, no dyspnea; category 1, slight degree of dyspnea (troubled by shortness of breath when hurrying on the level or walking up a slight hill); category 2, moderate degree of dyspnea (walks slower than people of the same age on the level because of breathlessness); category 3, moderately severe degree of dyspnea (has to stop because of breathlessness when walking at own pace on the level); category 4, severe degree of dyspnea (stops for breath after walking about 100 yards or after a few minutes on the level); category 5, very severe degree of dyspnea (too breathless to leave the house or breathless when dressing or undressing
|
base line and fourth week
|
|
Peak Flow Meter to assess change in pre and post
Time Frame: baseline and fourth week
|
Peak flow meter is mini spirometer which measures the PEFR .The Peak Expiratory Flow Rate (PEFR) is the maximum or peak flow rate that is attained during a forceful expiratory effort after taking a deep inspiration .Its normal range is 250 to 400 .
The Peak Expiratory Flow Rate (PEFR) is the maximum or peak flow rate that is attained during a forceful expiratory effort after taking a deep inspiration
|
baseline and fourth week
|
|
BCSS to assess change
Time Frame: baseline and fourth week
|
In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created.
The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness
|
baseline and fourth week
|
|
Oximeter to assess change
Time Frame: baseline and fourth week
|
A pulse oximeter measures the amount of oxygen that is carried by your blood.
Typically, a little clip is attached to the tip of your finger.
(On sometimes, the toe or earlobe are used.)
A light beam is projected through the skin using the gadget.
By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level.
Your oxygen saturation, often known as SpO2, is displayed on the screen
|
baseline and fourth week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Papaporfyriou A, Bakakos P, Hillas G, Papaioannou AI, Loukides S. Blood eosinophils in COPD: friend or foe? Expert Rev Respir Med. 2022 Jan;16(1):35-41. doi: 10.1080/17476348.2021.2011219. Epub 2021 Dec 3.
- Fei F, Koffman J, Zhang X, Gao W. Chronic Obstructive Pulmonary Disease Symptom Cluster Composition, Associated Factors, and Methodologies: A Systematic Review. West J Nurs Res. 2022 Apr;44(4):395-415. doi: 10.1177/0193945921995773. Epub 2021 Mar 6.
- 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.
- Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0321
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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