Back to resultsEffects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Autogenic drainage
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring Lung Clearance Index, Non cystic fibrosis Bronchiectasis, Multiple Breath Nitrogen Washout
Eligibility Criteria
Inclusion Criteria:
- Non cystic fibrosis bronchiectasis in stable state
Exclusion Criteria:
- Not in stable state
- Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Autogenic drainage
Arm Description
The autogenic drainage will be the chest physiotherapy technique used for this study. Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.
Outcomes
Primary Outcome Measures
Change of Lung Clearance Index (LCI)
LCI will me measured before and after the chest physiotherapy session
Secondary Outcome Measures
Change of Spirometry
Forced expired volume in one second (FEV1) and Forced expired flow at 25-75% of the forced vital capacity (FEF25-75) will be measured before and after the chest physiotherapy session
Sputum weight
Sputum will be collected during the 30 minutes of chest physiotherapy session and 5 minutes immediately after. Sputum weight will be measured and correlated with change of LCI and spirometry values
Full Information
NCT ID
NCT02411981
First Posted
April 3, 2015
Last Updated
March 19, 2016
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02411981
Brief Title
Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis
Official Title
Short-term Effects of Chest Physiotherapy on Ventilation Inhomogeneity in Non-CF Bronchiectasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.
Detailed Description
This is a before-after intervention study.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy.
The chest physiotherapy technique used will be autogenic drainage during 30 minutes. A resting period of 5 minutes will be given to the participant before the following tests.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Lung Clearance Index, Non cystic fibrosis Bronchiectasis, Multiple Breath Nitrogen Washout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autogenic drainage
Arm Type
Other
Arm Description
The autogenic drainage will be the chest physiotherapy technique used for this study.
Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.
Intervention Type
Other
Intervention Name(s)
Autogenic drainage
Primary Outcome Measure Information:
Title
Change of Lung Clearance Index (LCI)
Description
LCI will me measured before and after the chest physiotherapy session
Time Frame
up to 80 minutes
Secondary Outcome Measure Information:
Title
Change of Spirometry
Description
Forced expired volume in one second (FEV1) and Forced expired flow at 25-75% of the forced vital capacity (FEF25-75) will be measured before and after the chest physiotherapy session
Time Frame
up to 40 minutes
Title
Sputum weight
Description
Sputum will be collected during the 30 minutes of chest physiotherapy session and 5 minutes immediately after. Sputum weight will be measured and correlated with change of LCI and spirometry values
Time Frame
35 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non cystic fibrosis bronchiectasis in stable state
Exclusion Criteria:
Not in stable state
Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Gohy, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William Poncin, PhD student
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grégory Reychler, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
28223466
Citation
Poncin W, Reychler G, Leeuwerck N, Bauwens N, Aubriot AS, Nader C, Liistro G, Gohy S. Short-Term Effect of Autogenic Drainage on Ventilation Inhomogeneity in Adult Subjects With Stable Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2017 May;62(5):524-531. doi: 10.4187/respcare.05194. Epub 2017 Feb 21.
Results Reference
derived
Learn more about this trial
Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis
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