Chronic Obstructive Pulmonary DiseaseNCT00741832
The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Conical Positive Expiratory Pressure Device (C-PEP) in people with Chronic Obstructive Pulmonary Disease, run by Khon Kaen University at 1 site in Thailand.
Trial summary
From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that 1. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Conical Positive Expiratory Pressure Device (C-PEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2008to Feb 2009
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with stable mild-to-moderate COPD (Both stages: FEV1/FVC < 70%. Mild stage: FEV1 ≥ 80% predicted; Moderate stage: 50% ≤ FEV1 < 80% 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).
- Good communication
Who cannot join
- Older than 70 years old
- Musculoskeletal problems that limit mobility
- Cardiovascular disease
- Neurological or psychiatric illness
- Patient on long term oxygen or domiciliary noninvasive positive pressure ventilation
- 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
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen university
Khon Kaen, Changwat Khon Kaen, 40002
Tadsawiya Padkao, Bachelor, +6643202082, mjz_tad@yahoo.com
Tadsawiya Padkao, Bachelor
About this study
Official title: The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients
From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that
- Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
- PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
- PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.
Read the detailed description
Expiratory airflow limitation is the pathophysiological hallmark of chronic obstructive pulmonary disease (COPD) that leads to air trapping and increases in dynamic hyperinflation (DH) and consequently causes dyspnea during exercise. Although pursed lips breathing is a simple technique that provides a positive back pressure may retard the airway collapsed, but previous studies showed an unsuccessful reduction of DH which might cause by insufficient back pressure. And thereby a conical positive expiratory pressure (C-PEP) has been developed in our laboratory to generate back pressure higher than pursed lips breathing. Moreover, an effect of PEP on DH has not carried out in patient with COPD. Therefore, the objective of the present study was to examine effects of a C-PEP on DH and respiratory response during exercise in patient with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Conical Positive Expiratory Pressure Device (C-PEP), Control breathing
- Keywords
- chronic obstructive pulmonary disease, dynamic hyperinflation, dyspnea, recovery, positive expiratory pressure, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conical Positive Expiratory Pressure Device (C-PEP)Device
Conical positive expiratory pressure device (C-PEP) in this study was designed on the principle of expiratory flow retardation. The principle occurs when exhaling through a small tube diameter, i.e. a small straw, pursed lip breathing, or positive expiratory pressure. Expiratory retardation, results from a decrease in tube diameter, creates flow resistance during exhalation. With flow resistance, the greater the flow the greater the back pressure, and the less the flow the lower the pressure. Expiratory retardation was applied in an attempt to facilitate exhalation and to relieve the air trapping.
The optimal design was found to be: cone shape, proximal diameter is 2.0 cm, distal diameter is 0.6 cm, and length is 2.5 cm.
Subjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing with the C-PEP device.
Control breathingOther
Subjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing normally.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Patients breath while a conical positive expiratory pressure device during exercises Receives: Device: Conical Positive Expiratory Pressure Device (C-PEP) |
| C | Active comparator | Patients (normal) breath during exercise Receives: Other: Control breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Capacity
Measured: at 0th, 5th, ~20th minutes of exercises
Borg scale
Measured: at 0th and 20th minutes of exercises
Secondary outcomes (10)
Heart Rate
Measured: every minutes of exercise and recovery periods
Exercise time
Measured: at the times when participants stop exercises
Recovery time
Measured: the periods between end of symptomatic limited constance workload exercises to full recovery heart rate
Respiratory rate
Measured: every minutes of exercise and recovery periods
Inspiratory time
Measured: every minutes of exercise and recovery periods
Expiratory time
Measured: every minutes of exercise and recovery periods
Sp02
Measured: every minutes of exercise and recovery periods
PetCO2
Measured: every minutes of exercise and recovery periods
Mouth pressure
Measured: every minutes of exercise periods
Flow rate
Measured: every minutes of exercise periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Watchara Boonsawat, Philosophy, Study director, Department of medicine, Faculty of medicine, Khon Kaen universityTadsawiya Padkao, Bachelor, Study chair, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen universityChulee CU Jones, Philosophy, Study director, Phusical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741832
- Sponsor's protocol ID
- KKU-4950900021
- Status last verified
- Nov 2008
- First submitted
- 22 Aug 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Padkao T, Boonsawat W, Jones CU. Conical-PEP is safe, reduces lung hyperinflation and contributes to improved exercise endurance in patients with COPD: a randomised cross-over trial. J Physiother. 2010;56(1):33-9. doi: 10.1016/s1836-9553(10)70052-7.
PubMed 20500135
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients
- ClinicalTrials.gov ID
- NCT00741832
- Acronym / sponsor ID
- KKU-4950900021
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, dynamic hyperinflation, dyspnea, recovery, positive expiratory pressure, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 26 Aug 2008 (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.
From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that
- Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
- PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
- PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.
Detailed description
Expiratory airflow limitation is the pathophysiological hallmark of chronic obstructive pulmonary disease (COPD) that leads to air trapping and increases in dynamic hyperinflation (DH) and consequently causes dyspnea during exercise. Although pursed lips breathing is a simple technique that provides a positive back pressure may retard the airway collapsed, but previous studies showed an unsuccessful reduction of DH which might cause by insufficient back pressure. And thereby a conical positive expiratory pressure (C-PEP) has been developed in our laboratory to generate back pressure higher than pursed lips breathing. Moreover, an effect of PEP on DH has not carried out in patient with COPD. Therefore, the objective of the present study was to examine effects of a C-PEP on DH and respiratory response during exercise in patient with COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: Conical Positive Expiratory Pressure Device (C-PEP)Patients breath while a conical positive expiratory pressure device during exercises |
| C | Active comparator | Other: Control breathingPatients (normal) breath during exercise |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stable mild-to-moderate COPD (Both stages: FEV1/FVC < 70%. Mild stage: FEV1 ≥ 80% predicted; Moderate stage: 50% ≤ FEV1 < 80% 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).
- Good communication
Key exclusion criteria (6 listed)
- Older than 70 years old
- Musculoskeletal problems that limit mobility
- Cardiovascular disease
- Neurological or psychiatric illness
- Patient on long term oxygen or domiciliary noninvasive positive pressure ventilation
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 |
|---|---|---|
| Conical Positive Expiratory Pressure Device (C-PEP)Conical positive expiratory pressure device (C-PEP) in this study was designed on the principle of expiratory flow retardation. The principle occurs when exhaling through a small tube diameter, i.e. a small straw, pursed lip breathing, or positive expiratory pressure. Expiratory retardation, results from a decrease in tube diameter, creates flow resistance during exhalation. With flow resistance, the greater the flow the greater the back pressure, and the less the flow the lower the pressure. Expiratory retardation was applied in an attempt to facilitate exhalation and to relieve the air trapping. The optimal design was found to be: cone shape, proximal diameter is 2.0 cm, distal diameter is 0.6 cm, and length is 2.5 cm. Subjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing with the C-PEP device. | Device | I |
| Control breathingSubjects will rest for 10-15 minutes until HR, BP are stabilized. They will undertake 15 min of alternating quadriceps exercise (30% 1 RM) either breathing normally. | Other | C |
Primary outcome
Inspiratory Capacity
Time frame: at 0th, 5th, ~20th minutes of exercises
Borg scale
Time frame: at 0th and 20th minutes of exercises
10 secondary outcomes
Heart Rate
Time frame: every minutes of exercise and recovery periods
Exercise time
Time frame: at the times when participants stop exercises
Recovery time
Time frame: the periods between end of symptomatic limited constance workload exercises to full recovery heart rate
Respiratory rate
Time frame: every minutes of exercise and recovery periods
Inspiratory time
Time frame: every minutes of exercise and recovery periods
Expiratory time
Time frame: every minutes of exercise and recovery periods
Sp02
Time frame: every minutes of exercise and recovery periods
PetCO2
Time frame: every minutes of exercise and recovery periods
Mouth pressure
Time frame: every minutes of exercise periods
Flow rate
Time frame: every minutes of exercise periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Derived from this study: PubMed 20500135Padkao T, Boonsawat W, Jones CU. Conical-PEP is safe, reduces lung hyperinflation and contributes to improved exercise endurance in patients with COPD: a randomised cross-over trial. J Physiother. 2010;56(1):33-9. doi: 10.1016/s1836-9553(10)70052-7.
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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.
Watchara Boonsawat, Philosophy study director
Department of medicine, Faculty of medicine, Khon Kaen university
Tadsawiya Padkao, Bachelor study chair
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Chulee CU Jones, Philosophy study director
Phusical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conical Positive Expiratory Pressure Device (C-PEP) in people with Chronic Obstructive Pulmonary Disease, run by Khon Kaen University 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 3 inclusion and 6 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 14 Nov 2008. 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. 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 Tadsawiya Padkao, Bachelor (+6643202082, mjz_tad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory Capacity (time frame: at 0th, 5th, ~20th minutes of exercises). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741832, which also lists 1 linked publication.
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 14 Nov 2008.