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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357743
Other study ID # REC/00591 Mashaal Rana
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date February 10, 2020

Study information

Verified date April 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized control Trial, Purposive sampling was used to obtain the sample for the study and then randomly allocated into groups by coin toss method. Data collected from July 2019 to January 2020, was conducted at Rehman Medical Institute Peshawar. To determine the effects of pursed lip breathing with arm ergometry after chin support position on heart rate, respiratory parameters, pulmonary function tests and quality of life in COPD patients.


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


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date February 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Chin supported 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
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.

Locations

Country Name City State
Pakistan Department of Pulmonology of Rehman medical Institute. Peshawar Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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).

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 week
Primary Forced vital Capacity (FVC) Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters. 1 week
Primary 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. 1 week
Primary Oxygen Saturation (SpO2) 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
Primary Pulse Rate/Heart Rate Changes from the Baseline, It is the speed of Pulse/heart contractions per minute. It is measured by pulse oximeter 1 week
Primary Modified Borg Scale of Perceived Exertion 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 COPD Assessment Tool (CAT) 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
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