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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
This study is currently recruiting participants.
Verified by Khon Kaen University, November 2008
Sponsored by: Khon Kaen University
Information provided by: Khon Kaen University
ClinicalTrials.gov Identifier: NCT00741832
  Purpose

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.

Condition Intervention
Chronic Obstructive Pulmonary Disease
 Device: Conical Positive Expiratory Pressure Device (C-PEP)
Other: Control breathing

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title: The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Inspiratory Capacity [ Time Frame: at 0th, 5th, ~20th minutes of exercises ] [ Designated as safety issue: No ]
  • Borg scale [ Time Frame: at 0th and 20th minutes of exercises ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Heart Rate [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: Yes ]
  • Exercise time [ Time Frame: at the times when participants stop exercises ] [ Designated as safety issue: No ]
  • Recovery time [ Time Frame: the periods between end of symptomatic limited constance workload exercises to full recovery heart rate ] [ Designated as safety issue: No ]
  • Respiratory rate [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: Yes ]
  • Inspiratory time [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: No ]
  • Expiratory time [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: No ]
  • Sp02 [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: Yes ]
  • PetCO2 [ Time Frame: every minutes of exercise and recovery periods ] [ Designated as safety issue: Yes ]
  • Mouth pressure [ Time Frame: every minutes of exercise periods ] [ Designated as safety issue: Yes ]
  • Flow rate [ Time Frame: every minutes of exercise periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 11
Study Start Date: March 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
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.
C: Active Comparator
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.

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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741832

Contacts
Contact: Tadsawiya Padkao, Bachelor +6643202082 mjz_tad@yahoo.com
Contact: Chulee Jones, Philosophy +6643202399 chujones46@yahoo.co.uk

Locations
Thailand
Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen university Recruiting
Khon Kaen, Thailand, 40002
Contact: Tadsawiya Padkao, Bachelor     +6643202082     mjz_tad@yahoo.com    
Principal Investigator: Tadsawiya Padkao, Bachelor            
Sponsors and Collaborators
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
  More Information

Responsible Party: Khon Kaen university ( Graduate School )
Study ID Numbers: KKU-4950900021
Study First Received: August 22, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00741832  
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research;   Thailand: Ministry of Public Health

Keywords provided by Khon Kaen University:
chronic obstructive pulmonary disease
dynamic hyperinflation
dyspnea
 recovery
positive expiratory pressure
exercise

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
 Respiration Disorders
Dyspnea
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009



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