Effects of PEP on IC During IT in Patients With COPD | NCT03657082

Studies
Effects of PEP on IC During IT in Patients With COPD

NCT03657082

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Terminated

Last Update Posted

May 8, 2024Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

PEP-10
PEP-1

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No financial support found

Expanded Access Info

Start Date

Sep 15, 2018Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Aug 31, 2018

First Posted Date

Sep 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2024

Last Update Posted Date

May 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Poncin, PT, PhD, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	In this arm, patients will receive the experimental condition first, then the sham condition	Device: PEP-10 Device: PEP-1
Arm B	Experimental	In this arm, patients will receive the sham condition first, then the experimental condition	Device: PEP-10 Device: PEP-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEP-10	Device	Bottle PEP with a water level of 10 cmH2O	Arm A Arm B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided