Chronic Obstructive Pulmonary DiseaseNCT02398071
The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD
A study testing A water pressure threshold device (BreatheMAX) in people with Chronic Obstructive Pulmonary Disease, run by Khajonsak Pongpanit at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- A water pressure threshold device (BreatheMAX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Musculoskeletal problems that limit mobility
- Cardiovascular disease
- Neurological or psychiatric illness
- Any other comorbidities which would affect ability to undertake exercise test
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University
Khon Kaen, Muang Khon Kaen, 40002
Khajonsak Pongpanit, MSc student, +66832032415, p.khajonsak@gmail.com
Chulee Jones, PhD, +66845164169, joneschulee@gmail.com
About this study
Official title: 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
- 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- A water pressure threshold device (BreatheMAX)
- Keywords
- Positive Expiratory Pressure, Exercise Recovery, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A water pressure threshold device (BreatheMAX)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| PEP interventon | Experimental | Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O Receives: Device: A water pressure threshold device (BreatheMAX) |
| Sham intervention | Sham comparator | Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O Receives: Device: A water pressure threshold device (BreatheMAX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea rating (Rating of Perceived Breathlessness)
collect data every minute
Measured: 5 minutes of exercise, 10 minutes of recovery periods
Secondary outcomes (8)
Oxygen pulse saturation (SpO2)
collect data every minute
Measured: 5 minutes of exercise, 10 minutes of recovery periods
End tidal carbon dioxide pressure (PETCO2)
collect data every minute
Measured: 5 minutes of exercise and 10 minutes of recovery periods
Respiratory rate (RR)
collect data every minute
Measured: 5 minutes of exercise, 10 minutes of recovery periods
Expiratory flow rate
Measured: 10 minutes of recovery periods
Mouth pressure
Measured: 10 minutes of recovery periods
Inspiratory capacity (IC)
Measured: at 0th, 5th minutes of exercise
Inspiratory capacity (IC)
Measured: ~1st, 10th minutes of recovery periods
Heart rate (HR)
collect data every minute
Measured: 5 minutes of exercise, 10 minutes of recovery periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khajonsak Pongpanit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khajonsak Pongpanit, Khon Kaen University
- Investigators
- Chulee Jones, PhD, Study director, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, ThailandWatchara Boonsawat, PhD, Study chair, Department of medicine, Faculty of medicine, Khon Kaen university, ThailandDavid A. Jones, PhD, Study chair, School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, United KingdomKhajonsak Pongpanit, MSc student, Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398071
- Sponsor's protocol ID
- Khon Kaen University
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Breathing With a Positive Expiratory Pressure Device on The Rate of Post-exercise Recovery in Patients With COPD
- ClinicalTrials.gov ID
- NCT02398071
- Acronym / sponsor ID
- Khon Kaen University
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Positive Expiratory Pressure, Exercise Recovery, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Khajonsak PongpanitUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP interventon | Experimental | Device: A water pressure threshold device (BreatheMAX)Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O |
| Sham intervention | Sham comparator | Device: A water pressure threshold device (BreatheMAX)Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Musculoskeletal problems that limit mobility
- Cardiovascular disease
- Neurological or psychiatric illness
- Any other comorbidities which would affect ability to undertake exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | PEP interventon, Sham intervention |
Primary outcome
Dyspnea rating (Rating of Perceived Breathlessness)
Time frame: 5 minutes of exercise, 10 minutes of recovery periods
collect data every minute
8 secondary outcomes
Oxygen pulse saturation (SpO2)
Time frame: 5 minutes of exercise, 10 minutes of recovery periods
End tidal carbon dioxide pressure (PETCO2)
Time frame: 5 minutes of exercise and 10 minutes of recovery periods
Respiratory rate (RR)
Time frame: 5 minutes of exercise, 10 minutes of recovery periods
Expiratory flow rate
Time frame: 10 minutes of recovery periods
Mouth pressure
Time frame: 10 minutes of recovery periods
Inspiratory capacity (IC)
Time frame: at 0th, 5th minutes of exercise
Inspiratory capacity (IC)
Time frame: ~1st, 10th minutes of recovery periods
Heart rate (HR)
Time frame: 5 minutes of exercise, 10 minutes of recovery periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chulee Jones, PhD study director
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Watchara Boonsawat, PhD study chair
Department of medicine, Faculty of medicine, Khon Kaen university, Thailand
David A. Jones, PhD study chair
School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A water pressure threshold device (BreatheMAX) in people with Chronic Obstructive Pulmonary Disease, run by Khajonsak Pongpanit at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khajonsak Pongpanit, MSc student (+66832032415, p.khajonsak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea rating (Rating of Perceived Breathlessness) (time frame: 5 minutes of exercise, 10 minutes of recovery periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.