Effect of High Flow Nasal During Exercise in COPD Patients

NCT03058081 | Completed

• 1 other identifier: 2016-A01325-46
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients

Conditions

COPD Exacerbation

Keywords

COPD; Exercise; High Flow Nasal; Muscle Oxygenation; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Difference in exercise capacity

  Difference in endurance time (TLim) during High Intensity Constant Work-Rate Endurence Test (CWRET)

  The outcome will be measure after every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum

Secondary Outcomes (7)

• Difference in peripheral muscle oxygenation

  The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise

• Difference in Dyspnea and muscular fatigue

  The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected every 2 minute during tests and at the end of the exercise

• Difference in Oxygen Saturation

  The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise

• Difference in Cardiac Frequency

  The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise

• Difference in Transcutaneous Carbon Dioxide

  The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise

Study Arms (2)

High Flow Nasal Test

EXPERIMENTAL

Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with High Flow Nasal at 60L/min (with or without additional oxygen)

Device: High Flow nasal cannula

Control Test

NO INTERVENTION

Patient will perform one Constant Work-Rate Exercise Test at 80% of maximum workload on room air or with oxygen supplementation

Interventions

High Flow nasal cannula DEVICE

High intensity Constant Work-Rate exercise test with High Flow Nasal Cannula in COPD patients involved in a Pulmonary Rehabilitation Program after an exacerbation (\< 7 days after hospital discharge). High Flow nasal will be administered through nasal cannula using the Airvo2 (Fisher\&Paykel)

High Flow Nasal Test

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of COPD

You may not qualify if:

• exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
• pH \< 7,35
• Body temperature \> 38°C
• cardiac frequency \> 100 bpm at rest
• systolic blood pressure \< 100 mmHg
• exacerbation during the study

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe Hospitalier du Havre

Montivilliers, 76290, France

Location

Related Publications (2)

• Prieur G, Medrinal C, Combret Y, Dupuis Lozeron E, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Borel JC, Reychler G. Nasal high flow does not improve exercise tolerance in COPD patients recovering from acute exacerbation: A randomized crossover study. Respirology. 2019 Nov;24(11):1088-1094. doi: 10.1111/resp.13664. Epub 2019 Aug 6.

  PMID: 31387158 DERIVED

• Prieur G, Medrinal C, Combret Y, Quesada AR, Prieur F, Quieffin J, Borel JC, Reychler G. Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial. BMJ Open Respir Res. 2017 Aug 16;4(1):e000191. doi: 10.1136/bmjresp-2017-000191. eCollection 2017.

  PMID: 29071072 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

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: January 23, 2017
• First Posted: February 20, 2017
• Study Start: August 1, 2017
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)