Effects of PEP on IC During IT in Patients With COPD

NCT ID: NCT03657082

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type EXPERIMENTAL

PEP-10

Intervention Type DEVICE

Bottle PEP with a water level of 10 cmH2O

PEP-1

Intervention Type DEVICE

Bottle PEP with a water level of 1 cmH2O

Arm B

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

Group Type EXPERIMENTAL

PEP-10

Intervention Type DEVICE

Bottle PEP with a water level of 10 cmH2O

PEP-1

Intervention Type DEVICE

Bottle PEP with a water level of 1 cmH2O

Interventions

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PEP-10

Bottle PEP with a water level of 10 cmH2O

Intervention Type DEVICE

PEP-1

Bottle PEP with a water level of 1 cmH2O

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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William Poncin, PT, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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PEP-IC

Identifier Type: -

Identifier Source: org_study_id

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