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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: A water pressure threshold device (BreatheMAX)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Muang Khon Kaen
    • Khon Kaen, Muang Khon Kaen, Thailand, 40002
      • Recruiting
      • School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University
      • Contact: Khajonsak Pongpanit, MSc student; Phone Number: +66832032415; Email: p.khajonsak@gmail.com
      • Contact: Chulee Jones, PhD; Phone Number: +66845164169; Email: joneschulee@gmail.com
      • Principal Investigator: Khajonsak Pongpanit, MSc student
      • Sub-Investigator: Watchara Boonsawa, PhD
      • Sub-Investigator: David A. Jones, PhD
      • Sub-Investigator: Chulee Jones, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEP interventon; Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O	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.
Sham Comparator: Sham intervention; Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea rating (Rating of Perceived Breathlessness)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen pulse saturation (SpO2)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods
End tidal carbon dioxide pressure (PETCO2)	collect data every minute	5 minutes of exercise and 10 minutes of recovery periods
Respiratory rate (RR)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods
Expiratory flow rate		10 minutes of recovery periods
Mouth pressure		10 minutes of recovery periods
Inspiratory capacity (IC)		at 0th, 5th minutes of exercise
Inspiratory capacity (IC)		~1st, 10th minutes of recovery periods
Heart rate (HR)	collect data every minute	5 minutes of exercise, 10 minutes of recovery periods

Collaborators and Investigators

• Sponsor: Khajonsak Pongpanit
• Investigators: Study Director: Chulee Jones, PhD, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand; Study Chair: Watchara Boonsawat, PhD, Department of medicine, Faculty of medicine, Khon Kaen university, Thailand; Study Chair: David A. Jones, PhD, School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, United Kingdom; Principal Investigator: Khajonsak Pongpanit, MSc student, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: COPD; Positive Expiratory Pressure; Exercise Recovery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Khon Kaen University (Other Grant/Funding Number: Khon Kaen University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No