Effects of PEP on IC During IT in Patients With COPD

May 6, 2024 updated by: William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
In this arm, patients will receive the experimental condition first, then the sham condition
Device: PEP-10
Bottle PEP with a water level of 10 cmH2O
Device: PEP-1
Bottle PEP with a water level of 1 cmH2O
Experimental: Arm B
In this arm, patients will receive the sham condition first, then the experimental condition
Device: PEP-10
Bottle PEP with a water level of 10 cmH2O
Device: PEP-1
Bottle PEP with a water level of 1 cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inspiratory capacity
Time Frame: 20 minutes
Evolution of inspiratory capacity while performing the interval training session
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Borg scale
Time Frame: 20 minutes
Evolution of dyspnea while performing the interval training session
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP-IC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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