Chronic Obstructive Pulmonary DiseaseNCT05922267
Comparative Effects of ACBT and Slow Expiration in Patients With Chronic Obstructive Pulmonary Disease
A study testing ACTIVE CYCLE OF BREATHING TECHNIQUES and SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ACTIVE CYCLE OF BREATHING TECHNIQUES and SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both genders (Male and Female)
- 40-70 years
- Diagnosed COPD according to GOLD classification
- Hemodynamically stable patient
Who cannot join
- Patient with other disorders like cardiac and respiratory disorders
- Carcinoma
- Lung surgery
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ACTIVE CYCLE OF BREATHING TECHNIQUES, SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION
- Keywords
- COPD(chronic obstructive pulmonary disease),, ACBT(active cycle of breathing techniques), ELTGOL
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE CYCLE OF BREATHING TECHNIQUESOther
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
SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITIONOther
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
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Experimental | 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 Receives: Other: ACTIVE CYCLE OF BREATHING TECHNIQUES |
| SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION | Experimental | 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 Receives: Other: SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: base line and fourth week
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
Measured: baseline and fourth week
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
Measured: baseline and fourth week
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
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922267
- Sponsor's protocol ID
- REC/RCR&AHS/23/0321
- Status last verified
- Dec 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34821191Fei 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.
PubMed 33682534Zisi 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.
PubMed 35235877Munoz 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.
PubMed 29326318
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05922267
- Acronym / sponsor ID
- REC/RCR&AHS/23/0321
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD(chronic obstructive pulmonary disease),, ACBT(active cycle of breathing techniques), ELTGOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Experimental | Other: ACTIVE CYCLE OF BREATHING TECHNIQUESTry 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 |
| SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION | Experimental | Other: SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITIONThe 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders (Male and Female)
- 40-70 years
- Diagnosed COPD according to GOLD classification
- Hemodynamically stable patient
Key exclusion criteria (4 listed)
- Patient with other disorders like cardiac and respiratory disorders
- Carcinoma
- Lung surgery
- Neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVE CYCLE OF BREATHING TECHNIQUESThe 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 | Other | Active cycle of breathing technique |
| SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITIONThe 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 | Other | SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 34821191Papaporfyriou 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.
- Background: PubMed 33682534Fei 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.
- Background: PubMed 35235877Zisi 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.
- Background: PubMed 29326318Munoz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE CYCLE OF BREATHING TECHNIQUES and SLOW EXPIRATION WITH OPEN GLOTTIS IN LATERAL POSITION in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea scale to assess change in pre and post (time frame: base line and fourth week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922267, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.