The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
A water pressure threshold device (BreatheMAX)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Positive Expiratory Pressure, Exercise Recovery, COPD
Eligibility Criteria
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
Sites / Locations
- School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
PEP interventon
Sham intervention
Arm Description
Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O
Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O
Outcomes
Primary Outcome Measures
Dyspnea rating (Rating of Perceived Breathlessness)
collect data every minute
Secondary Outcome Measures
Oxygen pulse saturation (SpO2)
collect data every minute
End tidal carbon dioxide pressure (PETCO2)
collect data every minute
Respiratory rate (RR)
collect data every minute
Expiratory flow rate
Mouth pressure
Inspiratory capacity (IC)
Inspiratory capacity (IC)
Heart rate (HR)
collect data every minute
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02398071
Brief Title
The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD
Official Title
The Effects of Breathing With a Positive Expiratory Pressure Device on The Rate of Post-exercise Recovery in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khajonsak Pongpanit
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Post-exercise breathing with PEP device will increase the rate of recovery more than breathing without PEP device.
Post-exercise breathing with PEP device will not create harmful effects on cardiopulmonary function in COPD patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Positive Expiratory Pressure, Exercise Recovery, COPD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEP interventon
Arm Type
Experimental
Arm Description
Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O
Arm Title
Sham intervention
Arm Type
Sham Comparator
Arm Description
Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O
Intervention Type
Device
Intervention Name(s)
A water pressure threshold device (BreatheMAX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspnea rating (Rating of Perceived Breathlessness)
Description
collect data every minute
Time Frame
5 minutes of exercise, 10 minutes of recovery periods
Secondary Outcome Measure Information:
Title
Oxygen pulse saturation (SpO2)
Description
collect data every minute
Time Frame
5 minutes of exercise, 10 minutes of recovery periods
Title
End tidal carbon dioxide pressure (PETCO2)
Description
collect data every minute
Time Frame
5 minutes of exercise and 10 minutes of recovery periods
Title
Respiratory rate (RR)
Description
collect data every minute
Time Frame
5 minutes of exercise, 10 minutes of recovery periods
Title
Expiratory flow rate
Time Frame
10 minutes of recovery periods
Title
Mouth pressure
Time Frame
10 minutes of recovery periods
Title
Inspiratory capacity (IC)
Time Frame
at 0th, 5th minutes of exercise
Title
Inspiratory capacity (IC)
Time Frame
~1st, 10th minutes of recovery periods
Title
Heart rate (HR)
Description
collect data every minute
Time Frame
5 minutes of exercise, 10 minutes of recovery periods
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khajonsak Pongpanit, MSc student
Phone
+66832032415
Email
p.khajonsak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulee Jones, PhD
Organizational Affiliation
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Watchara Boonsawat, PhD
Organizational Affiliation
Department of medicine, Faculty of medicine, Khon Kaen university, Thailand
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David A. Jones, PhD
Organizational Affiliation
School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, United Kingdom
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khajonsak Pongpanit, MSc student
Organizational Affiliation
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University
City
Khon Kaen
State/Province
Muang Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khajonsak Pongpanit, MSc student
Phone
+66832032415
Email
p.khajonsak@gmail.com
First Name & Middle Initial & Last Name & Degree
Chulee Jones, PhD
Phone
+66845164169
Email
joneschulee@gmail.com
First Name & Middle Initial & Last Name & Degree
Khajonsak Pongpanit, MSc student
First Name & Middle Initial & Last Name & Degree
Watchara Boonsawa, PhD
First Name & Middle Initial & Last Name & Degree
David A. Jones, PhD
First Name & Middle Initial & Last Name & Degree
Chulee Jones, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD
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