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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02411981
Other study ID # StLuc MBWN2 03
Secondary ID
Status Recruiting
Phase N/A
First received April 3, 2015
Last updated July 31, 2015
Start date April 2015
Est. completion date October 2015

Study information

Verified date July 2015
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact William Poncin, PhD student
Email william.poncin@uclouvain.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date October 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Autogenic drainage


Locations

Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Lung Clearance Index (LCI) LCI will me measured before and after the chest physiotherapy session up to 80 minutes No
Secondary 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 up to 40 minutes No
Secondary 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 35 minutes No
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