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

NCT00741832 | Unknown DMC

• 1 other identifier: KKU-4950900021
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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. 1.Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
2. 2.PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
3. 3.PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Inspiratory Capacity

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

• Borg scale

  at 0th and 20th minutes of exercises

Secondary Outcomes (10)

• 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

Study Arms (2)

I

EXPERIMENTAL

Patients breath while a conical positive expiratory pressure device during exercises

Device: Conical Positive Expiratory Pressure Device (C-PEP)

C

ACTIVE COMPARATOR

Patients (normal) breath during exercise

Other: Control breathing

Interventions

Conical Positive Expiratory Pressure Device (C-PEP) 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.

I

Control breathing 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.

C

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

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

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 20500135 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• Watchara Boonsawat, Philosophy

  Department of medicine, Faculty of medicine, Khon Kaen university

  STUDY DIRECTOR

• Tadsawiya Padkao, Bachelor

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

  STUDY CHAIR

• Chulee CU Jones, Philosophy

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

  STUDY DIRECTOR

Central Study Contacts

Tadsawiya Padkao, Bachelor

CONTACT

+6643202082; mjz_tad@yahoo.com

Chulee Jones, Philosophy

CONTACT

+6643202399; chujones46@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 14, 2008

Record last verified: 2008-11

Locations

TH (1)