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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Conical Positive Expiratory Pressure Device (C-PEP)

Control breathing

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, dynamic hyperinflation, dyspnea, recovery, positive expiratory pressure, exercise

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Patients breath while a conical positive expiratory pressure device during exercises

Patients (normal) breath during exercise

Outcomes

Primary Outcome Measures

Inspiratory Capacity

Borg scale

Secondary Outcome Measures

Heart Rate

Exercise time

Recovery time

Respiratory rate

Inspiratory time

Expiratory time

Sp02

PetCO2

Mouth pressure

Flow rate

Full Information

NCT ID

NCT00741832

First Posted

August 22, 2008

Last Updated

November 13, 2008

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT00741832

Brief Title

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

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

February 2009 (Anticipated)

Study Completion Date

February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients breath while a conical positive expiratory pressure device during exercises

Arm Title

Arm Type

Active Comparator

Arm Description

Patients (normal) breath during exercise

Intervention Type

Device

Intervention Name(s)

Conical Positive Expiratory Pressure Device (C-PEP)

Intervention Description

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

Other

Intervention Name(s)

Control breathing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Inspiratory Capacity

Time Frame

at 0th, 5th, ~20th minutes of exercises

Title

Borg scale

Time Frame

at 0th and 20th minutes of exercises

Secondary Outcome Measure Information:

Title

Heart Rate

Time Frame

every minutes of exercise and recovery periods

Title

Exercise time

Time Frame

at the times when participants stop exercises

Title

Recovery time

Time Frame

the periods between end of symptomatic limited constance workload exercises to full recovery heart rate

Title

Respiratory rate

Time Frame

every minutes of exercise and recovery periods

Title

Inspiratory time

Time Frame

every minutes of exercise and recovery periods

Title

Expiratory time

Time Frame

every minutes of exercise and recovery periods

Title

Sp02

Time Frame

every minutes of exercise and recovery periods

Title

PetCO2

Time Frame

every minutes of exercise and recovery periods

Title

Mouth pressure

Time Frame

every minutes of exercise periods

Title

Flow rate

Time Frame

every minutes of exercise periods

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tadsawiya Padkao, Bachelor

Phone

+6643202082

mjz_tad@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chulee Jones, Philosophy

Phone

+6643202399

chujones46@yahoo.co.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Watchara Boonsawat, Philosophy

Organizational Affiliation

Department of medicine, Faculty of medicine, Khon Kaen university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tadsawiya Padkao, Bachelor

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Chulee CU Jones, Philosophy

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tadsawiya Padkao, Bachelor

Phone

+6643202082

mjz_tad@yahoo.com

First Name & Middle Initial & Last Name & Degree

Tadsawiya Padkao, Bachelor

12. IPD Sharing Statement

Citations:

PubMed Identifier

20500135

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.

Results Reference

derived

Learn more about this trial

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

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