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Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ACTIVE CYCLE OF BREATHING TECHNIQUES
SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD(chronic obstructive pulmonary disease),, ACBT(active cycle of breathing techniques), ELTGOL

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active cycle of breathing technique

SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION

Arm Description

Try to keep your chest Take a long, slow and deep breath in, through your nose if you can. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing Breathe out gently and relaxed, like a sigh. Don't force the air out. Repeat 3 - 5 times. If the patient feels light-headed then it is important that they revert back to the breathing control phase of the cycle Huffing

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

Outcomes

Primary Outcome Measures

Dyspnea scale to assess change in pre and post
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
Peak Flow Meter to assess change in pre and post
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
BCSS to assess change
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
Oximeter to assess change
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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05922267
Brief Title
Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Comparative Effects of Active Cycle of Breathing Techniques and Slow Expiration With Open Glottis in Lateral Posture in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD(chronic obstructive pulmonary disease),, ACBT(active cycle of breathing techniques), ELTGOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active cycle of breathing technique
Arm Type
Experimental
Arm Description
Try to keep your chest Take a long, slow and deep breath in, through your nose if you can. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing Breathe out gently and relaxed, like a sigh. Don't force the air out. Repeat 3 - 5 times. If the patient feels light-headed then it is important that they revert back to the breathing control phase of the cycle Huffing
Arm Title
SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ACTIVE CYCLE OF BREATHING TECHNIQUES
Intervention Description
The participants in group A will be given ACBT with conventional chest physiotherapy . Instruction for patient Try to keep your chest Take a long, slow and deep breath in, through your nose if you can. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing Breathe out gently and relaxed, like a sigh. Don't force the air out. Repeat 3 - 5 times. If the patient feels light-headed then it is important that they revert back to the breathing control phase of the cycle Huffing
Intervention Type
Other
Intervention Name(s)
SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
Intervention Description
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
Primary Outcome Measure Information:
Title
Dyspnea scale to assess change in pre and post
Description
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
Time Frame
base line and fourth week
Title
Peak Flow Meter to assess change in pre and post
Description
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
Time Frame
baseline and fourth week
Title
BCSS to assess change
Description
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
Time Frame
baseline and fourth week
Title
Oximeter to assess change
Description
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
Time Frame
baseline and fourth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IQBAL TARIQ, PHD
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Phone
03124378540
Email
sidra.afzal@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34821191
Citation
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.
Results Reference
background
PubMed Identifier
33682534
Citation
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.
Results Reference
background
PubMed Identifier
35235877
Citation
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.
Results Reference
background
PubMed Identifier
29326318
Citation
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.
Results Reference
background

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Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease

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