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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Conical Positive Expiratory Pressure Device (C-PEP); Other: Control breathing

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 Type: Interventional
• Enrollment (Anticipated): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University
    • Contact: Tadsawiya Padkao, Bachelor; Phone Number: +6643202082; Email: mjz_tad@yahoo.com
    • Principal Investigator: Tadsawiya Padkao, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I; Patients breath while a conical positive expiratory pressure device during exercises	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.
Active Comparator: C; Patients (normal) breath during exercise	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inspiratory Capacity	at 0th, 5th, ~20th minutes of exercises
Borg scale	at 0th and 20th minutes of exercises

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart Rate	every minutes of exercise and recovery periods
Exercise time	at the times when participants stop exercises
Recovery time	the periods between end of symptomatic limited constance workload exercises to full recovery heart rate
Respiratory rate	every minutes of exercise and recovery periods
Inspiratory time	every minutes of exercise and recovery periods
Expiratory time	every minutes of exercise and recovery periods
Sp02	every minutes of exercise and recovery periods
PetCO2	every minutes of exercise and recovery periods
Mouth pressure	every minutes of exercise periods
Flow rate	every minutes of exercise periods

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Study Director: Watchara Boonsawat, Philosophy, Department of Medicine, Faculty of Medicine, Khon Kaen University; Study Chair: Tadsawiya Padkao, Bachelor, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university; Study Director: Chulee CU Jones, Philosophy, Phusical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: August 22, 2008
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): November 14, 2008
• Last Update Submitted That Met QC Criteria: November 13, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: positive expiratory pressure; exercise; recovery; dyspnea; chronic obstructive pulmonary disease; dynamic hyperinflation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: KKU-4950900021