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

NCT ID: NCT00741832

Last Updated: 2008-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-02-28

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; dynamic hyperinflation; dyspnea; recovery; positive expiratory pressure; exercise

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

I

Patients breath while a conical positive expiratory pressure device during exercises

Group Type: EXPERIMENTAL

Conical Positive Expiratory Pressure Device (C-PEP)

Intervention Type: 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.

C

Patients (normal) breath during exercise

Group Type: ACTIVE_COMPARATOR

Control breathing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Khon Kaen university

Principal Investigators

Watchara Boonsawat, Philosophy

Role: STUDY_DIRECTOR

Department of medicine, Faculty of medicine, Khon Kaen university

Tadsawiya Padkao, Bachelor

Role: STUDY_CHAIR

Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

Chulee CU Jones, Philosophy

Role: STUDY_DIRECTOR

Phusical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand

Locations

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen university

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Tadsawiya Padkao, Bachelor

Role: CONTACT

Phone: +6643202082

Email: mjz_tad@yahoo.com

Chulee Jones, Philosophy

Role: CONTACT

Phone: +6643202399

Email: chujones46@yahoo.co.uk

Facility Contacts

Tadsawiya Padkao, Bachelor

Role: primary

References

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.

Reference Type: DERIVED

PMID: 20500135 (View on PubMed)

Other Identifiers

KKU-4950900021

Identifier Type: -

Identifier Source: org_study_id