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Effects of PEP on IC During IT in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

PEP-10

PEP-1

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

In this arm, patients will receive the experimental condition first, then the sham condition

In this arm, patients will receive the sham condition first, then the experimental condition

Outcomes

Primary Outcome Measures

Change in inspiratory capacity

Evolution of inspiratory capacity while performing the interval training session

Secondary Outcome Measures

Change in Borg scale

Evolution of dyspnea while performing the interval training session

Full Information

NCT ID

NCT03657082

First Posted

August 28, 2018

Last Updated

November 1, 2020

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03657082

Brief Title

Effects of PEP on IC During IT in Patients With COPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2018 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

In this arm, patients will receive the experimental condition first, then the sham condition

Arm Title

Arm B

Arm Type

Experimental

Arm Description

In this arm, patients will receive the sham condition first, then the experimental condition

Intervention Type

Device

Intervention Name(s)

PEP-10

Intervention Description

Bottle PEP with a water level of 10 cmH2O

Intervention Type

Device

Intervention Name(s)

PEP-1

Intervention Description

Bottle PEP with a water level of 1 cmH2O

Primary Outcome Measure Information:

Title

Change in inspiratory capacity

Description

Evolution of inspiratory capacity while performing the interval training session

Time Frame

20 minutes

Secondary Outcome Measure Information:

Title

Change in Borg scale

Description

Evolution of dyspnea while performing the interval training session

Time Frame

20 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Poncin

Phone

003227641633

william.poncin@uclouvain.be

12. IPD Sharing Statement

Learn more about this trial

Effects of PEP on IC During IT in Patients With COPD

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