COPD ExacerbationAiRehabNCT03058081
Effect of High Flow Nasal During Exercise in COPD Patients
A study testing High Flow nasal cannula in people with COPD Exacerbation, run by Groupe Hospitalier du Havre at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- High Flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2017to 18 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of COPD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation
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
- Being tested
- High Flow nasal cannula
- Keywords
- COPD, Exercise, High Flow Nasal, Muscle Oxygenation, Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal cannulaDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in exercise capacity
Difference in endurance time (TLim) during High Intensity Constant Work-Rate Endurence Test (CWRET)
Measured: 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
Muscle oxygenation will be evaluated using Near-infrared spectroscopy technology.
Measured: 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
Difference in dyspnea and muscular fatigue using Modified Borg Scale (0 - 10 points)
Measured: 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
Difference in Oxygen Saturation using a pulse oximetry (SpO2)
Measured: 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
Difference in Cardiac Frequence using a pulse oximetry
Measured: 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
Difference Transcutaneous Carbon Dioxide using Transcutaneous Carbon Dioxide using a Transcutaneous capnography
Measured: 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
Difference in Respiratory Rate using a Respiratory Inductive Plethysmography
Measured: 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 Muscle Fatigue
Difference in Respiratory Muscle Fatigue using an electronical manometer
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Aug 2017
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058081
- Sponsor's protocol ID
- 2016-A01325-46
- Acronym
- AiRehab
- Status last verified
- May 2018
- First submitted
- 23 Jan 2017
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31387158Prieur 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.
PubMed 29071072
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation
- ClinicalTrials.gov ID
- NCT03058081
- Acronym / sponsor ID
- AiRehab / 2016-A01325-46
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Exercise, High Flow Nasal, Muscle Oxygenation, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Test | Experimental | Device: High Flow nasal cannulaPatients 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) |
| 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 |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of COPD
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow nasal cannulaHigh 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) | Device | High Flow Nasal Test |
Primary outcome
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)
7 secondary outcomes
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
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 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 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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 31387158Prieur 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.
- Derived from this study: PubMed 29071072Prieur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow nasal cannula in people with COPD Exacerbation, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058081, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.