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
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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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