The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effects of Breathing With a Positive Expiratory Pressure Device on The Rate of Post-exercise Recovery in Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398071
• Other study ID #: Khon Kaen University
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 19, 2015
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Khon Kaen University
• Contact: Khajonsak Pongpanit, MSc student
• Phone: +66832032415
• Email: p.khajonsak[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

Most daily activities involve alternating periods of exercise and rest. If recovery is slow following exercise it means that the next period of activity may be more difficult and the COPD patients becomes restricted in their daily life. Therefore, the investigators are interested to study the effectiveness and physiological effects of breathing with a PEP device during post-exercise period and hypothesize that

1. Post-exercise breathing with PEP device will increase the rate of recovery more than breathing without PEP device.

2. Post-exercise breathing with PEP device will not create harmful effects on cardiopulmonary function in COPD patients.

Description:

Chronic obstructive pulmonary disease (COPD) was the 4th leading cause of morbidity and mortality worldwide in 2012 and represents an important public health challenge that is both preventable and treatable. COPD is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases.

The pathophysiological hallmark of COPD is an expiratory air flow limitation. During exercise, increasing ventilatory demands can induce premature airway closure by forced expiration leading to air trapping and further leading to lung hyperinflation. Dynamic hyperinflation (DH) during exercise contributes to increased end expiratory lung volume (EELV), reduces inspiratory capacity (IC), and increases the mechanical load on inspiratory muscles leading to dyspnea, exercise intolerance, limited physical activity, and thus to a poor quality of life in COPD patients. In addition, abnormal lung mechanical function during dynamic hyperinflation leads to increased sensation of dyspnea, which is the disparity between respiratory drive and the respiratory mechanical response. Abnormal controls of blood chemicals and of vasculature factors also aggravate the sensation of dyspnea.

The autonomic dysfunction (AD) that occurs in the patients with COPD is evident as an inability of heart rate to reach an appropriate level during exercise (chronotropic incompetence; CI). There is also a prolonged heart rate recovery (HRR) at the end of exercise which may contribute to increase dyspnea sensations and increased mortality rate in COPD.

Expiratory flow retardation when breathing with a positive expiratory pressure (PEP) device is the one of various techniques to manage dyspnea in COPD. Most studies using a PEP device have focused on investigating the effects of PEP to reduce lung hyperinflation, reduce dyspnea, and increase exercise capacity. Only one study of Martin and Devenport, has examined the effects of PEP breathing during the recovery periods after exercise and found that following 6 minutes sub-maximal treadmill walking, 6 breath exhalation against a 10 cmH2O threshold PEP reduced dyspnea and increased HRR. Oxygen pulse saturation (SpO2) was also increased within 2 minutes although there was no statistical significant between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with moderate to severe COPD (both stages: FEV1/FVC < 70%, moderate stage:

50% = FEV1 < 80% predicted, severe stage: 30% = FEV1 < 50% predicted according to Global Initiative Obstructive Lung Disease (GOLD) guideline

• Free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or ER or unscheduled clinic visit)

• Age between 40-70 years old

• Good communication

Exclusion Criteria:

• Musculoskeletal problems that limit mobility

• Cardiovascular disease

• Neurological or psychiatric illness

• Any other comorbidities which would affect ability to undertake exercise test

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• A water pressure threshold device (BreatheMAX)
BreatheMAX®, the water pressure threshold breathing device contributed in our laboratory will be used. This device is small, simple, easy to use and also inexpensive since the device is developed and manufactured in Thailand. The depth of water in the body of the device provides the flow resistance during exhalation through the inlet tube in a water cylinder.

Locations

Country	Name	City	State
Thailand	School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University	Khon Kaen	Muang Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khajonsak Pongpanit

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea rating (Rating of Perceived Breathlessness)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods	Yes
Secondary	Oxygen pulse saturation (SpO2)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods	Yes
Secondary	End tidal carbon dioxide pressure (PETCO2)	collect data every minute	5 minutes of exercise and 10 minutes of recovery periods	Yes
Secondary	Respiratory rate (RR)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods	Yes
Secondary	Expiratory flow rate		10 minutes of recovery periods	No
Secondary	Mouth pressure		10 minutes of recovery periods	No
Secondary	Inspiratory capacity (IC)		at 0th, 5th minutes of exercise	No
Secondary	Inspiratory capacity (IC)		~1st, 10th minutes of recovery periods	No
Secondary	Heart rate (HR)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods	Yes