Effects of PEP on IC During IT in Patients With COPD

NCT03657082 | Terminated

• 1 other identifier: PEP-IC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory capacity

  Evolution of inspiratory capacity while performing the interval training session

  20 minutes

Secondary Outcomes (1)

• Change in Borg scale

  20 minutes

Study Arms (2)

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

PEP-10 DEVICE

Bottle PEP with a water level of 10 cmH2O

Arm A; Arm B

PEP-1 DEVICE

Bottle PEP with a water level of 1 cmH2O

Arm A; Arm B

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable COPD since 1 month at least
• Able to understand the instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 4, 2018
• Study Start: September 15, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BE (1)