High-flow Nasal Cannula and Exercise Tolerance in COPD

NCT04350970 | Completed

• 1 other identifier: 3.009.159
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. The objective was to evaluate and compare the acute effects of HFNT and NIV during exercise on cardiorespiratory parameters, dyspnea, exercise tolerance and comfort in patients with moderate to severe COPD.

Conditions

COPD; Rehabilitation; Exercise

Keywords

COPD; High flow nasal therapy; Non-invasive ventilation

Outcome Measures

Primary Outcomes (2)

• Exercise dinamic hyperinflation

  To determine the dinamic hyperinflation during exercise test with 3-different situations , Control, NIV and HFNT. During all testes the dinamic hyperinflation will be measured by inspiratory capacity (at rest and at the end o exercise test) and will be demonstrated as porcentage os maximum.

  one week after all tests

• Exercise Tolerance

  To determine the exercise tolerance with 3-different situations , Control, NIV and HFNT. Time of exercise test will be measured to determine which test could be the best for COPD patients. In additional, the workload will (treadmill inclination and speed) be check to show which intervention has the better response.

  one week after all tests

Secondary Outcomes (1)

• Dyspnea

  one week after all tests

Study Arms (3)

Control

ACTIVE COMPARATOR

The cardiopulmonary exercise test was performed with patient breathing room air.

Other: Control

NIV

ACTIVE COMPARATOR

The cardiopulmonary exercise test was performed with non-invasive ventilation during the test.

Other: Non-invasive ventilation

HFNT

ACTIVE COMPARATOR

The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test.

Other: High flow nasal therapy

Interventions

High flow nasal therapy OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test.

HFNT

Non-invasive ventilation OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test.

NIV

Control OTHER

All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy.

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous COPD
• FEV1 ≤ 50%
• Optimized medication

You may not qualify if:

• COPD Exacerbation
• Cardiac disease
• Previous neurologic disorders
• Unable to complete all protocol

Sponsors & Collaborators

• Marcelo Alcantara Holanda: lead

Study Sites (1)

Federal University of Ceara

Fortaleza, Ceará, 60.430-370, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: One single COPD group performed 3 differents tests, Control exercise, VNI exercise and HFNT exercise on different days.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: January 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)