Back to resultsThe Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BottlePEP
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with COPD
- Stable Disease
Exclusion Criteria:
- Neuromuscular disease
- Recent pneumothorax
- Major surgery in the last 6 months
Sites / Locations
- Marmara University School of Medicine Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bottle PEP
Control
Arm Description
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 interventions will be applied.
Outcomes
Primary Outcome Measures
Forced expiratory volume in the first minute
Pulmonary function tests that are done with a spirometry to measure forced expiratory volume
Secondary Outcome Measures
6 minute walking test
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03900195
Brief Title
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Official Title
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bottle PEP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No interventions will be applied.
Intervention Type
Other
Intervention Name(s)
BottlePEP
Intervention Description
Positive expiratory device with a bottle
Primary Outcome Measure Information:
Title
Forced expiratory volume in the first minute
Description
Pulmonary function tests that are done with a spirometry to measure forced expiratory volume
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
6 minute walking test
Description
6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period.
Time Frame
6 months after intervention
Title
St. George's Quality of Life Score
Description
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.
Time Frame
6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with COPD
Stable Disease
Exclusion Criteria:
Neuromuscular disease
Recent pneumothorax
Major surgery in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozge Kenis Coskun, Asisstant Prof.
Phone
+905058294947
Email
ozgekenis@gmail.com
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozge Kenis-Coskun, MD
Phone
5058294947
Email
ozgekenis@gmail.com
First Name & Middle Initial & Last Name & Degree
MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
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