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Completed

NCT Number: NCT03058081

Effect of High Flow Nasal During Exercise in COPD Patients

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

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Key information

Conditions

COPD Exacerbation Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier du Havre

Montivilliers, 76290, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of COPD

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Difference in exercise capacity

    Time frame: 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

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

Secondary outcomes

  1. Difference in peripheral muscle oxygenation

    Time frame: 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

    Muscle oxygenation will be evaluated using Near-infrared spectroscopy technology.

  2. Difference in Dyspnea and muscular fatigue

    Time frame: 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 dyspnea and muscular fatigue using Modified Borg Scale (0 - 10 points)

  3. Difference in Oxygen Saturation

    Time frame: 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 Oxygen Saturation using a pulse oximetry (SpO2)

  4. Difference in Cardiac Frequency

    Time frame: 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 Frequence using a pulse oximetry

  5. Difference in Transcutaneous Carbon Dioxide

    Time frame: 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 Transcutaneous Carbon Dioxide using Transcutaneous Carbon Dioxide using a Transcutaneous capnography

  6. Difference in Respiratory Rate

    Time frame: 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 Respiratory Rate using a Respiratory Inductive Plethysmography

  7. Difference in Respiratory Muscle Fatigue

    Time frame: 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 before and 5 minute maximum after exercise

    Difference in Respiratory Muscle Fatigue using an electronical manometer

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation

Acronym: AiRehab

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2017
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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