Clinical trial NCT00741832: The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
dynamic hyperinflation
dyspnea
recovery
positive expiratory pressure
exercise
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 11
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that

1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
2. PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inspiratory Capacity
timeFrame: at 0th, 5th, ~20th minutes of exercises
measure: Borg scale
timeFrame: at 0th and 20th minutes of exercises
Secondary outcomes:
measure: Heart Rate
timeFrame: every minutes of exercise and recovery periods
measure: Exercise time
timeFrame: at the times when participants stop exercises
measure: Recovery time
timeFrame: the periods between end of symptomatic limited constance workload exercises to full recovery heart rate
measure: Respiratory rate
timeFrame: every minutes of exercise and recovery periods
measure: Inspiratory time
timeFrame: every minutes of exercise and recovery periods
measure: Expiratory time
timeFrame: every minutes of exercise and recovery periods
measure: Sp02
timeFrame: every minutes of exercise and recovery periods
measure: PetCO2
timeFrame: every minutes of exercise and recovery periods
measure: Mouth pressure
timeFrame: every minutes of exercise periods
measure: Flow rate
timeFrame: every minutes of exercise periods
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen university
Study officials:
affiliation: Department of medicine, Faculty of medicine, Khon Kaen university
name: Watchara Boonsawat, Philosophy
role: STUDY_DIRECTOR
affiliation: Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
name: Tadsawiya Padkao, Bachelor
role: STUDY_CHAIR
affiliation: Phusical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand
name: Chulee CU Jones, Philosophy
role: STUDY_DIRECTOR
References:
citation: 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.