Chronic Obstructive Pulmonary DiseaseRePox-1NCT02055885
Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD
An observational study of Chronic Obstructive Pulmonary Disease and Oxygen/Therapeutic Use, run by 5 Santé at 2 sites in France.
Trial summary
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Oxygen/Therapeutic Use
- How many people
- 255 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2014to Jul 2015
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic obstructive pulmonary disease and exhibiting an exercise-induced desaturation during six minute walkink test.
Who may be able to join
- Obstructive airflow limitation defined by FEV1/CVF < 70% and FEV1 < 80 %
- Patients with or without long terme oxygenotherapy
- Patients exhibited during the first test, an exercise-induced desaturation, defined by SaO2 < 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-LTOT or with the flow normally recommended during exercise for LTOT patients (i.e., flow rate of rest + 1L/min)
- Patients with no desaturation during the test with oxygen supply
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique du Souffle La Vallonie
Lodève, 34800
Clinique du Souffle La Solane
Osséjà, 66340
About this study
Official title: Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.
The aims of this retrospective study was :
- To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
- To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program
Read the detailed description
During this study, a retrospective data collection will be carried out using the informations contained in the medical folders of patients admitted in our centers for pulmonary rehabiliation program.
We will select patients who meet the following criteria:
- patients having two 6WT early in their program B) who desaturate (SpO2 <90% for 3 consecutive min) during the first 6WT and who will have been properly corrected with a supply of oxygen during the second walk test.
The analyzed parameters will be distance and dyspnea during the tests
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive responders | Positive responders (R+): patients exhibiting an increase in the 6WT distance ≥ 10% and/or a decrease in dyspnea ≥ 10% (i.e., ≥ 1 point on the visual analogue scale). | |
| negative responders | Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance of six minute walking test (meter)
Measured: Baseline
Secondary outcomes (1)
Dyspnea during the 6 minute walking test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly N HERAUD, Pd-D, Study director, 5 Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055885
- Sponsor's protocol ID
- Fvie_RePox-1
- Acronym
- RePox-1
- Status last verified
- Jul 2015
- First submitted
- 4 Feb 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heraud N, Prefaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10.
PubMed 18619828
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?
- ClinicalTrials.gov ID
- NCT02055885
- Acronym / sponsor ID
- RePox-1 / Fvie_RePox-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Feb 2014 (estimated)
- 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.
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.
The aims of this retrospective study was :
- To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
- To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program
Detailed description
During this study, a retrospective data collection will be carried out using the informations contained in the medical folders of patients admitted in our centers for pulmonary rehabiliation program.
We will select patients who meet the following criteria:
- patients having two 6WT early in their program B) who desaturate (SpO2 <90% for 3 consecutive min) during the first 6WT and who will have been properly corrected with a supply of oxygen during the second walk test.
The analyzed parameters will be distance and dyspnea during the tests
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive responders | – | –Positive responders (R+): patients exhibiting an increase in the 6WT distance ≥ 10% and/or a decrease in dyspnea ≥ 10% (i.e., ≥ 1 point on the visual analogue scale). |
| negative responders | – | –Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic obstructive pulmonary disease and exhibiting an exercise-induced desaturation during six minute walkink test.
Key inclusion criteria (4 listed)
- Obstructive airflow limitation defined by FEV1/CVF < 70% and FEV1 < 80 %
- Patients with or without long terme oxygenotherapy
- Patients exhibited during the first test, an exercise-induced desaturation, defined by SaO2 < 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-LTOT or with the flow normally recommended during exercise for LTOT patients (i.e., flow rate of rest + 1L/min)
- Patients with no desaturation during the test with oxygen supply
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance of six minute walking test (meter)
Time frame: Baseline
1 secondary outcome
Dyspnea during the 6 minute walking test
Time frame: Baseline
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 8 Jul 2015.
- Background: PubMed 18619828Heraud N, Prefaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Nelly N HERAUD, Pd-D study director
5 Santé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Oxygen/Therapeutic Use, run by 5 Santé at 2 sites 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 4 inclusion and 0 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Distance of six minute walking test (meter) (time frame: Baseline). 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 NCT02055885, which also lists 1 linked publication.
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 8 Jul 2015.