Effects of PEP on IC During IT in Patients With COPD

Not Applicable

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: PEP-10; Device: PEP-1

• Registration Number: NCT03657082
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Study Start: 2018-09-15
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A	PEP-1	In this arm, patients will receive the experimental condition first, then the sham condition
Arm B	PEP-10	In this arm, patients will receive the sham condition first, then the experimental condition
Arm A	PEP-10	In this arm, patients will receive the experimental condition first, then the sham condition
Arm B	PEP-1	In this arm, patients will receive the sham condition first, then the experimental condition

Primary Outcome Measures

Name	Time	Method
Change in inspiratory capacity	20 minutes	Evolution of inspiratory capacity while performing the interval training session

Secondary Outcome Measures

Name	Time	Method
Change in Borg scale	20 minutes	Evolution of dyspnea while performing the interval training session

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium