The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00741832
• Other study ID #: KKU-4950900021
• Status: Unknown status
• Phase: N/A
• First received: August 22, 2008
• Last updated: November 13, 2008
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2008
• Source: Khon Kaen University
• Contact: Tadsawiya Padkao, Bachelor
• Phone: +6643202082
• Email: mjz_tad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 11
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Other:
• Control breathing
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.

Locations

Country	Name	City	State
Thailand	Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen university	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory Capacity		at 0th, 5th, ~20th minutes of exercises
Primary	Borg scale		at 0th and 20th minutes of exercises
Secondary	Heart Rate		every minutes of exercise and recovery periods
Secondary	Exercise time		at the times when participants stop exercises
Secondary	Recovery time		the periods between end of symptomatic limited constance workload exercises to full recovery heart rate
Secondary	Respiratory rate		every minutes of exercise and recovery periods
Secondary	Inspiratory time		every minutes of exercise and recovery periods
Secondary	Expiratory time		every minutes of exercise and recovery periods
Secondary	Sp02		every minutes of exercise and recovery periods
Secondary	PetCO2		every minutes of exercise and recovery periods
Secondary	Mouth pressure		every minutes of exercise periods
Secondary	Flow rate		every minutes of exercise periods