The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

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

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: BottlePEP

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Recruiting
    • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with COPD
• Stable Disease

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: BottlePEP; Positive expiratory device with a bottle
No Intervention: Control; No interventions will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: March 30, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 30, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 09.2019.052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No