- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04357743
Pursed Lip Breathing With Arm Ergometry After Chin Supported Position in COPD Patients.
Effects of Pursed Lip Breathing With Arm Ergometry After Chin Supported Position in COPD Patients.
Study Overview
Status
Conditions
Detailed Description
Chronic Obstructive Lung Disease (COPD), a major worldwide epidemic is the 4th leading cause of death around the globe and though, with rise in worldwide life expectancy and tobacco smoking, predominantly in developing countries, it is likely to be the 3rd leading cause of mortality by 2020. In Pakistan, mortality rate caused by COPD is expected to reach 71 deaths per 100,000 that is globally the fourth leading death rate among 25 most populated countries.
The condition is in the focus worldwide, since its increased prevalence, morbidity and mortality rate create alarming challenges for health-care professionals. In spite of latest trends in decline of COPD consistent death rates and few current achievements in anti-smoking efforts in many western countries, the elevating influence of increasing age in an ever-growing global population, combined with factors as high smoking rates and pollution of air in Asia, will confirm that COPD will last as an ever-increasing issue into the 21st century.
A variety of environmental and intrinsic risk factors are involved in the development of COPD which affect at different time points during an individual's life span. Smoking is a dominant risk factor comprising of 80% of the COPD cases.
During the previous 5 years, an exceeding quantity of risk factors excluding smoking have been associated with the COPD development, predominantly in developing countries.
Exercise intolerance is a challenging result of COPD and often happens during arm activities. . Exercise intolerance can be best described by the concept of dynamic hyperinflation. The thoracic motion is regulated due to hyperinflation and thus capacity to increase tidal volume during exercise is limited. Many research studies have established that there is limited arm exercise capacity, and patients often complain of notable dyspnea and fatigue during arm activities essential in daily life. Two mechanisms have been recommended: neuro-mechanical dysfunction of respiratory musculature, that are diaphragm and accessory respiratory muscles, thoracic-abdominal asynchronous and changes in lung volume during upper limb activities. Impairments in ventilatory mechanics in COPD patients result in termination of arm exercises at lower workloads compared with healthy subjects.
When these patients were asked to open their mouths to breathe out instead of using pursed lips Breathing (PLB) they immediately developed severe dyspnea and suffocation. The term PLB was utilized as the patients had lips almost completely sealed while they were exhaling. However, the term pursed lip or puckered lip breathing was not well characterized, and the techniques taught to patients varied depending on the clinician. PLB was defined as a self-induced type of positive-pressure breath. One definition given by Wikipedia, is that PLB is a breathing technique that consists of exhaling through tightly pressed lip (pursed lips) and inhaling through nose with mouth closed. The "tightly" is the word that can be subjective and open to interpretation. The online free medical dictionary gives a very similar definition as Wikipedia; however, it removed "tightly" from the "tightly pursed lip". Regardless of "tightly pursed lip" vs. "pressed lip", the purpose of this breathing is to slow down the air flow during the exhalation to build up back pressure in the airway to avoid a sudden drop in intra-pulmonary pressure resulting in alveolar and airway collapse. Pursed lip breathing, is a strategic breathing training often used by COPD patients to obtain relief from dyspnea.
A shift in the pattern of recruitment of inspiratory and expiratory muscles with PLB exercise. There is a better activity in the rib cage and accessory muscles than with activity of diaphragm. The diaphragmatic tension-time index is decreased. Consequently, PLB by altering recruitment pattern decreases the possibility of fatigue of diaphragm and improves breathlessness. It also upsurges recruitment of abdominal expiratory musculature. Expiratory muscle recruitment does not only ease expiration but also aids in inspiration by developing the length-tension relationship of the inspiratory muscles.
Body positioning is one of the controlled breathing maneuvers to improve the respiratory muscle functioning and decreasing dyspnea. That is why the COPD patients often assume the tripod position, which is, sitting with forward lean of trunk and arm support, during breathlessness. This position develops the length-tension relationship of diaphragm and decreases the activity of sternocleidomastoid and scalene muscles thus improving thoraco-abdominal movement and reducing breathlessness. The arm support in this position recruits pectoralis major and pectoralis minor musculature to improve rib elevation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Department of Pulmonology of Rehman medical Institute.
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to moderate stage COPD according to GOLD criteria {i-e Global Initiative for Obstructive Lung Disease (GOLD) }
Exclusion Criteria:
- COPD patient with angina pectoris,
- third degree heart block,
- congestive heart failure and
- orthopedic or neuromuscular conditions (cervical involvement which aggravate symptoms) or radiculopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chin supported Arm ergometry with pursed lip breathing
Chin supported along with Arm ergometry with pursed lip breathing
|
The participants sat in chin support position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes. The participants again sat in chin support position for 10 minutes. The treatment was provided for one week |
|
Active Comparator: Arm ergometry with pursed lip breathing
|
The participants sat in normal position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes; the participants again sat in sitting position for 10 minutes. The treatment was provided for one week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 1 week
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
|
1 week
|
|
Forced vital Capacity (FVC)
Time Frame: 1 week
|
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
|
1 week
|
|
Peak Expiratory Flow (PEF)
Time Frame: 1 week
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
|
1 week
|
|
Oxygen Saturation (SpO2)
Time Frame: 1 week
|
Changes from baseline SPO2 was measured in percentage.
Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood.
Pulse oximeter measure it.
|
1 week
|
|
Pulse Rate/Heart Rate
Time Frame: 1 week
|
Changes from the Baseline, It is the speed of Pulse/heart contractions per minute.
It is measured by pulse oximeter
|
1 week
|
|
Modified Borg Scale of Perceived Exertion
Time Frame: 1 week
|
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea."
A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COPD Assessment Tool (CAT)
Time Frame: 1 week
|
Changes from the baseline, CAT is a tool to assess the burden in COPD and is not a diagnostic tool.
It is recommended by GOLD guidelines 2018.
It is an eight item questionnaire with a scoring range of 0 to 40.
It is categorized into four groups, that are, low(1) , medium(2), high(3) and very high(4) based on the level of effect of the disease on status of health.
CAT has reliability of 0.85 to 0.98
|
1 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
- Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.
- Halldin CN, Doney BC, Hnizdo E. Changes in prevalence of chronic obstructive pulmonary disease and asthma in the US population and associated risk factors. Chron Respir Dis. 2015 Feb;12(1):47-60. doi: 10.1177/1479972314562409. Epub 2014 Dec 24.
- Tunkamnerdthai O, Auvichayapat P, Punjaruk W, Manimmanakorn A, Leelayuwat N, Boonsawat W, et al. Modified Arm Swing Exercise Improves Oxidative Stress and Heart Rate Variability in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Journal of Exercise Physiology Online. 2018;21(4)
- Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.
- Xu J, He S, Han Y, Pan J, Cao L. Effects of modified pulmonary rehabilitation on patients with moderate to severe chronic obstructive pulmonary disease: A randomized controlled trail. Int J Nurs Sci. 2017 Jun 27;4(3):219-224. doi: 10.1016/j.ijnss.2017.06.011. eCollection 2017 Jul 10. Erratum In: Int J Nurs Sci. 2022 Jul 14;9(3):405.
- Bharadwaj TA, Jiandani MP, Mehta A. PURSED LIP BREATHING INCREASES UNSUPPORTED UPPER EXTREMITY EXERCISE ENDURANCE AND REDUCES DESATURATION IN COPD. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2016;21(38).
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/00591 Mashaal Rana
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
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