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NCT03657082 Clinical Trial

Effects of PEP on IC During IT in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Effects of Positive Expiratory Pressure on Inspiratory Capacity and Dyspnea in Patients With COPD During Exercise

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03657082
Other study ID # PEP-IC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date December 30, 2021

Study information
Verified date November 2020
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effects of positive expiratory pressure (PEP) on hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Inspiratory capacity (IC) is the primary outcome

Description:

This is a cross-over intervention assessing the effect of PEP on IC and dyspnea in patients with COPD performing an interval training (IT) session. IC will be measured before, during and immediately after the IT session. Each participant will receive perform IT sessions including either the use of a PEP of 10 cmH2O or a PEP of 1 cmH2O. The effects on IC and dyspnea on both PEP levels will be assessed.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 95 Years
Eligibility Inclusion Criteria: - Stable COPD since 1 month at least - Able to understand the instructions Exclusion Criteria: - COPD with a forced expiratory volume at one second > 80% of predicted values - In exacerbation - Orthopedic of neurological condition likely to interfere with the experimentation - Contraindication to perform exercise

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PEP-10
Bottle PEP with a water level of 10 cmH2O
• PEP-1
Bottle PEP with a water level of 1 cmH2O

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 in inspiratory capacity Evolution of inspiratory capacity while performing the interval training session 20 minutes
Secondary Change in Borg scale Evolution of dyspnea while performing the interval training session 20 minutes
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