COPDNCT04138069
Imposed Pursed Lip Breathing at Rest and During Exercise In COPD
A study testing PLB+Aerobic Bicycling and Aerobic Bicycling in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
A randomized control trial was conducted at physiotherapy department of Pakistan Railway General Hospital from July 2017 to Dec 2017. 30 patients with stable COPD were enrolled in the study on the basis of inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- COPD
- What is being tested?
- PLB+Aerobic Bicycling and Aerobic Bicycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2017to 30 Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD stage 2 and 3 patients [based on "Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria]
Who cannot join
- neurological disorder and
- cardiovascular disorder
- Impaired lower limbs mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Imposed Pursed Lips Breathing on Breathing Pattern, Dyspnea and Pulmonary Function Test at Rest and During Exercise in COPD Patients
A randomized control trial was conducted at physiotherapy department of Pakistan Railway General Hospital from July 2017 to Dec 2017. 30 patients with stable COPD were enrolled in the study on the basis of inclusion and exclusion criteria. The participants were randomly assigned into two groups, Group A= interventional group, Group B = control group through toss and coin method using non-probability convenient sampling technique and written consent was obtained from each patient participated in the study. From 30 patients 15 patients were randomly allocated to each group, Group A: Interventional (n= 15), Group B: Control (n=15). 1 patient in control group B was dropout because he didn't come for follow up. Overall 29 patients were evaluated for study as in Group A, interventional (n=15) and Group B control (n=14).Patients in group A were performed breathing control at the start of session and then Purse lips breathing technique during aerobic bicycling for 8 min while in group B patients first perform breathing control and then aerobic bicycling for 8 min. Subjects in both experimental and control group underwent spirometry and baseline vitals, such as Respiratory rate, blood pressure, and oxygen saturation, at rest and at the completion of session was noted. Borg scale of dyspnea also used to rate the level of dyspnea at rest and at the end of session. Clinical COPD Questionnaire (CCQ) was used at 1st and final week of evaluation. It was 6 weeks training protocol, with three days per week session was given to the patient.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a main and growing worldwide prevailing disease that has lacking consideration from medical practitioners. COPD is self-imposed by cigarette smoking and underlying pathology is commonly irreparable. This is main reason of morbidity and mortality in under developing countries, so quick response is necessary to be aware of disease signs and symptoms to provide valuable impediment and management programs.
In U.S public survey the way prevalence of COPD has figure out by questioning adult population in case they had one of seventeen pulmonary diseases in previous months. Asthma, bronchitis and emphysema listed in these 17 diseases to approximate the cases for prevalence of disease. In era of 2000, approx. 10 million people diagnosed with COPD by doctor. Along this calculation large ratio of COPD-ers left over under diagnosed. In different countries the occurrence rate varies from 3.5% in Hong Kong and Singapore to 6.7% in Vietnam. Taken as a whole the prevalence rate is higher in Asian Pacific countries about 6.3% as compared to World Health Organisation (WHO) report data that hypothesized the figure of 3.8%.
Dyspnea is a main cause for seek medical advice or referral to pharmacotherapy and pulmonary rehabilitation regimes to lessen the inflammation and spasm of airways in addition to self management approach for example breathing retraining techniques. COPD patients have inadequate exhalation time because of increased resistance in the airways with increase chance of collapse. While doing exercise airflow limitation exacerbates that leads to air trapping with shortened exhalation phase. This is noticeable by increase in expiratory lung volumes which causes reduction in exercise capacity that might be restricted by fatigue of their lower limb muscles other than the ventilatory causes. The disease severity can be decided through the intenseness of breathlessness therefore the primary aim of COPD management is dyspnea reduction.
Commonly used strategy for ventilatory pattern training is purse lips breathing technique (PLB). PLB is supposed to alter the ventilatory pattern as a result of that breathlessness is decreased. The action of PLB technique is to improve exhalation and prevent airway obstruction. The patient performs expiration actively by means of partly opened mouth by applying pressure of 5cm of water (H2O).
PLB reduces rapid and prolong breathing and causes increased level of Carbon dioxide (CO2) in alveoli. These improved levels may dilate the airway smooth muscles and V/Q ratio and O2 in circulation. PLB is worked by generating back pressure in airways in a way to open up the narrowed airways. It is also create positive pressure during expiratory phase to prolong the exhalation time in order to decrease expiratory lung volumes and increase in tidal volume.
Patients with emphysema and bronchial atelectasis tried to perform PLB the expired air volume increased as compared to forced exhalation. This proposed that patient expires in a relaxed manner with PLB which causes less air trapping and also reduced dynamic hyperinflation.
In 2012 a randomized control study conducted on 14 stable COPD patients to rule out the effects of imposed purse lips breathing on exercise tolerance. In this study it has been shown that at rest PLB improves gaseous exchange, breathing pattern and lessen the respiratory rate near to normal.As in COPD patients' diaphragm hyperinflate due to air trapping by performing this breathing technique, diaphragm brings to a vantage point.
In COPD metabolic disruption in skeletal muscles is a main factor for exercise intolerance. Previous Investigators compared the upper and lower limb activities in COPD patients presented with obvious dyspnea and limited active daily living (ADLs). In COPD-ers due to decreased strength and endurance are correlated with early sarcopenia, reduced capacity of aerobic exercises and rapid collection of lactic acid while doing exercise these factors possible culprits for muscle fatigue. Aerobic training is well known and consistent in the improvement of disease symptoms, exercise tolerance and quality of life in patients with COPD. According to data of various studies cycle ergometer (CET) is commonly used training to increase strength and endurance in lower limb musculature. In one study results CET can cause physiological effects on COPD patients thought to improve O2 uptake \& minute tidal volume with reduction in pulse rate, sensation of breathlessness and muscle fatigue.
In Pakistan about 6-7 million people have suffering due to COPD and death rate is 71 for each 10000 population. Although the demand for such strategies is considerable but at the same time the facility to grant these services is deprived. When talk about data on application of purse lips breathing technique in COPD patients, very few researches are found in Pakistan. Currently in Peshawar work on chest physiotherapy for worsening symptoms of COPD is reported. If the implication of these techniques in symptoms free period of disease this might be cause improvement in health related quality of life. The present study is to determine the effects of imposed purse lips breathing technique on dyspnea, breathing pattern and pulmonary function testing during rest and exercise in patients with COPD.
- Conditions
- COPD
- Being tested
- PLB+Aerobic Bicycling, Aerobic Bicycling
- Keywords
- COPD, Pursed Lips Breathing, Dyspnea, Pulmonary Function Test (PFT), Aerobic Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLB+Aerobic BicyclingOther
Combination of Breathing control and Purse lips breathing technique for 5 minutes at the start of session.
Purse lips breathing with aerobic bicycling for 8 minutes
Aerobic BicyclingOther
Breathing control for 5 minutes at the start of session.
Aerobic bicycling for 8 minutes
| Study group | Role | What they receive |
|---|---|---|
| PLB+Aerobic Bicycling | Experimental | Pursed Lip Breathing + Aerobic Bicycling Receives: Other: PLB+Aerobic Bicycling |
| Aerobic Bicycling | Active comparator | Only Aerobic bicycling Receives: Other: Aerobic Bicycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 6th week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 6th week
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 6th week
Secondary outcomes (1)
Breathing Pattern
Changes from the baseline, Breathing pattern was measured through observation and countercheck with respiratory rate which was taken by researcher by observing chest movements counting the breaths for one minute.
Measured: 6th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jul 2017
- Primary completion25 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138069
- Sponsor's protocol ID
- REC/00228 Madeeha Shafeeq
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Imposed Pursed Lips Breathing on Breathing Pattern, Dyspnea and Pulmonary Function Test at Rest and During Exercise in COPD Patients
- ClinicalTrials.gov ID
- NCT04138069
- Acronym / sponsor ID
- REC/00228 Madeeha Shafeeq
- Conditions
- COPD
- Keywords
- COPD, Pursed Lips Breathing, Dyspnea, Pulmonary Function Test (PFT), Aerobic Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 24 Oct 2019 (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.
A randomized control trial was conducted at physiotherapy department of Pakistan Railway General Hospital from July 2017 to Dec 2017. 30 patients with stable COPD were enrolled in the study on the basis of inclusion and exclusion criteria. The participants were randomly assigned into two groups, Group A= interventional group, Group B = control group through toss and coin method using non-probability convenient sampling technique and written consent was obtained from each patient participated in the study. From 30 patients 15 patients were randomly allocated to each group, Group A: Interventional (n= 15), Group B: Control (n=15). 1 patient in control group B was dropout because he didn't come for follow up. Overall 29 patients were evaluated for study as in Group A, interventional (n=15) and Group B control (n=14).Patients in group A were performed breathing control at the start of session and then Purse lips breathing technique during aerobic bicycling for 8 min while in group B patients first perform breathing control and then aerobic bicycling for 8 min. Subjects in both experimental and control group underwent spirometry and baseline vitals, such as Respiratory rate, blood pressure, and oxygen saturation, at rest and at the completion of session was noted. Borg scale of dyspnea also used to rate the level of dyspnea at rest and at the end of session. Clinical COPD Questionnaire (CCQ) was used at 1st and final week of evaluation. It was 6 weeks training protocol, with three days per week session was given to the patient.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a main and growing worldwide prevailing disease that has lacking consideration from medical practitioners. COPD is self-imposed by cigarette smoking and underlying pathology is commonly irreparable. This is main reason of morbidity and mortality in under developing countries, so quick response is necessary to be aware of disease signs and symptoms to provide valuable impediment and management programs.
In U.S public survey the way prevalence of COPD has figure out by questioning adult population in case they had one of seventeen pulmonary diseases in previous months. Asthma, bronchitis and emphysema listed in these 17 diseases to approximate the cases for prevalence of disease. In era of 2000, approx. 10 million people diagnosed with COPD by doctor. Along this calculation large ratio of COPD-ers left over under diagnosed. In different countries the occurrence rate varies from 3.5% in Hong Kong and Singapore to 6.7% in Vietnam. Taken as a whole the prevalence rate is higher in Asian Pacific countries about 6.3% as compared to World Health Organisation (WHO) report data that hypothesized the figure of 3.8%.
Dyspnea is a main cause for seek medical advice or referral to pharmacotherapy and pulmonary rehabilitation regimes to lessen the inflammation and spasm of airways in addition to self management approach for example breathing retraining techniques. COPD patients have inadequate exhalation time because of increased resistance in the airways with increase chance of collapse. While doing exercise airflow limitation exacerbates that leads to air trapping with shortened exhalation phase. This is noticeable by increase in expiratory lung volumes which causes reduction in exercise capacity that might be restricted by fatigue of their lower limb muscles other than the ventilatory causes. The disease severity can be decided through the intenseness of breathlessness therefore the primary aim of COPD management is dyspnea reduction.
Commonly used strategy for ventilatory pattern training is purse lips breathing technique (PLB). PLB is supposed to alter the ventilatory pattern as a result of that breathlessness is decreased. The action of PLB technique is to improve exhalation and prevent airway obstruction. The patient performs expiration actively by means of partly opened mouth by applying pressure of 5cm of water (H2O).
PLB reduces rapid and prolong breathing and causes increased level of Carbon dioxide (CO2) in alveoli. These improved levels may dilate the airway smooth muscles and V/Q ratio and O2 in circulation. PLB is worked by generating back pressure in airways in a way to open up the narrowed airways. It is also create positive pressure during expiratory phase to prolong the exhalation time in order to decrease expiratory lung volumes and increase in tidal volume.
Patients with emphysema and bronchial atelectasis tried to perform PLB the expired air volume increased as compared to forced exhalation. This proposed that patient expires in a relaxed manner with PLB which causes less air trapping and also reduced dynamic hyperinflation.
In 2012 a randomized control study conducted on 14 stable COPD patients to rule out the effects of imposed purse lips breathing on exercise tolerance. In this study it has been shown that at rest PLB improves gaseous exchange, breathing pattern and lessen the respiratory rate near to normal.As in COPD patients' diaphragm hyperinflate due to air trapping by performing this breathing technique, diaphragm brings to a vantage point.
In COPD metabolic disruption in skeletal muscles is a main factor for exercise intolerance. Previous Investigators compared the upper and lower limb activities in COPD patients presented with obvious dyspnea and limited active daily living (ADLs). In COPD-ers due to decreased strength and endurance are correlated with early sarcopenia, reduced capacity of aerobic exercises and rapid collection of lactic acid while doing exercise these factors possible culprits for muscle fatigue. Aerobic training is well known and consistent in the improvement of disease symptoms, exercise tolerance and quality of life in patients with COPD. According to data of various studies cycle ergometer (CET) is commonly used training to increase strength and endurance in lower limb musculature. In one study results CET can cause physiological effects on COPD patients thought to improve O2 uptake \& minute tidal volume with reduction in pulse rate, sensation of breathlessness and muscle fatigue.
In Pakistan about 6-7 million people have suffering due to COPD and death rate is 71 for each 10000 population. Although the demand for such strategies is considerable but at the same time the facility to grant these services is deprived. When talk about data on application of purse lips breathing technique in COPD patients, very few researches are found in Pakistan. Currently in Peshawar work on chest physiotherapy for worsening symptoms of COPD is reported. If the implication of these techniques in symptoms free period of disease this might be cause improvement in health related quality of life. The present study is to determine the effects of imposed purse lips breathing technique on dyspnea, breathing pattern and pulmonary function testing during rest and exercise in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLB+Aerobic Bicycling | Experimental | Other: PLB+Aerobic BicyclingPursed Lip Breathing + Aerobic Bicycling |
| Aerobic Bicycling | Active comparator | Other: Aerobic BicyclingOnly Aerobic bicycling |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD stage 2 and 3 patients [based on "Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria]
Key exclusion criteria (3 listed)
- neurological disorder and
- cardiovascular disorder
- Impaired lower limbs mobility
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 |
|---|---|---|
| PLB+Aerobic BicyclingCombination of Breathing control and Purse lips breathing technique for 5 minutes at the start of session. Purse lips breathing with aerobic bicycling for 8 minutes | Other | PLB+Aerobic Bicycling |
| Aerobic BicyclingBreathing control for 5 minutes at the start of session. Aerobic bicycling for 8 minutes | Other | Aerobic Bicycling |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 6th week
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow (PEF)
Time frame: 6th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
1 secondary outcome
Breathing Pattern
Time frame: 6th weeks
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 13 Jan 2020.
- 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.
Iqbal Tariq, MsCPPT 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 PLB+Aerobic Bicycling and Aerobic Bicycling in people with COPD, 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 1 inclusion and 3 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 13 Jan 2020. 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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.