The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

Overview

The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2020

Interventions

  • Other: BottlePEP
    • Positive expiratory device with a bottle

Arms, Groups and Cohorts

  • Experimental: Bottle PEP
    • Bottle PEP is a positive expiratory system that is applied via a tube of more than 5 mm of thickness and a bottle filled with water about 10 cms.
  • No Intervention: Control
    • No interventions will be applied.

Clinical Trial Outcome Measures

Primary Measures

  • Forced expiratory volume in the first minute
    • Time Frame: 6 months after intervention
    • Pulmonary function tests that are done with a spirometry to measure forced expiratory volume

Secondary Measures

  • 6 minute walking test
    • Time Frame: 6 months after intervention
    • 6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period.
  • St. George’s Quality of Life Score
    • Time Frame: 6 months after intervention
    • Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. This score has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with COPD
  • Stable Disease

Exclusion Criteria

  • Neuromuscular disease
  • Recent pneumothorax
  • Major surgery in the last 6 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Marmara University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Ozge Kenis Coskun, Asisstant Prof., +905058294947, ozgekenis@gmail.com

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