High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)

NCT02860273 | Completed DMC

• 1 other identifier: 2728
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.

Conditions

COPD

Keywords

Pulmonary Rehabilitation; COPD; High Flow Nasal Cannula; HFNC; Aerobic capacity

Outcome Measures

Primary Outcomes (1)

• Difference in Exercise capacity - Maximun Walking Time Tolerated

  Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air

  Baseline and 48 hs after baseline

Secondary Outcomes (8)

• Difference in Dyspnea

  Baseline and 48 hs after baseline

• Difference in Cardiac Rate

  Baseline and 48 hs after baseline

• Difference in Oxygen Saturation

  Baseline and 48 hs after baseline

• Difference in Global Comfort

  Baseline and 48 hs after baseline

• Difference in Lower Limbs Fatigue

  Baseline and 48 hs after baseline

Study Arms (2)

High Flow Nasal Cannula Oxygen

EXPERIMENTAL

1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21% 2. Constant Treadmill Load Test (CTLT) using HFNCO at 21%

Device: High Flow Nasal Cannula Oxygen

Control Group

OTHER

1. Incremental Load Treadmill Test (ILTT) at Room Air 2. Constant Treadmill Load Test (CTLT) at Room Air

Device: Treadmill

Interventions

High Flow Nasal Cannula Oxygen DEVICE

Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.

Also known as: HFNCO

High Flow Nasal Cannula Oxygen

Treadmill DEVICE

Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.

Control Group

Eligibility Criteria

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

You may qualify if:

• Clinically stable defined as four weeks without exacerbation.
• Signed Informed consent

You may not qualify if:

• Long term oxygen therapy (LTOT) or oxygen needs during exercise
• Any neuromuscular or cardiovascular condition that limits test performance
• Refusal to participate
• Contraindication for exercise

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Related Publications (25)

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• Sivori M, Almeida M, Benzo R, Boim C, Brassesco M, Callejas O, Capparelli I, Conti E, Diaz M, Draghi J, Franco J, Gando S, Giuliano G, Guida R, Jolly E, Pessolano F, Rabinovich R, Ratto P, Rhodius E, Saadia M, Salvado A, Sobrino E, Victorio C. [New argentine consensus of respiratory rehabilitation 2008]. Medicina (B Aires). 2008;68(4):325-44. Spanish.

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Related Links

• Global initiative for Chronic Obstructive Lung Disease. Update 2016

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Nicolás NR Roux, PT-RT

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: August 9, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 22, 2023

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)