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NCT03900195 Clinical Trial

The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03900195
Other study ID # 09.2019.052
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date January 2020

Study information
Verified date March 2019
Source Marmara University
Contact Ozge Kenis Coskun, Asisstant Prof.
Phone +905058294947
Email ozgekenis@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosed with COPD

- Stable Disease

Exclusion Criteria:

- Neuromuscular disease

- Recent pneumothorax

- Major surgery in the last 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• BottlePEP
Positive expiratory device with a bottle

Locations
Country Name City State
Turkey Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Forced expiratory volume in the first minute Pulmonary function tests that are done with a spirometry to measure forced expiratory volume 6 months after intervention
Secondary 6 minute walking test 6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period. 6 months after intervention
Secondary St. George's Quality of Life Score 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.		 6 months after intervention
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