The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT03900195|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: BottlePEP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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.
Positive expiratory device with a bottle
No Intervention: Control
No interventions will be applied.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900195
|Contact: Ozge Kenis Coskun, Asisstant Prof.||+firstname.lastname@example.org|
|Marmara University School of Medicine Department of Physical Medicine and Rehabilitation||Recruiting|
|Istanbul, Turkey, 34899|
|Contact: Ozge Kenis-Coskun, MD 5058294947 email@example.com|
|Contact: , MD|