Pulmonary Disease, Chronic ObstructiveFIBOXNCT05235685
Neuromuscular Fatigue During Exercise in COPD-HF Overlap
A study testing Medical air and Hyperoxia in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Rationale. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) coexist in approximately one third of patients presenting with one of these conditions. From a clinical standpoint, impaired tissue oxygen (O2) delivery stands as a common pathological mechanism of these cardiorespiratory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Heart Failure
- What is being tested?
- Medical air and Hyperoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2023to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- COPD: mild-to-severe airflow obstruction (forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio <0.70; post-bronchodilator FEV1 > 30% predicted);
- HF: reduced left ventricular ejection fraction (<50%, for COPD-HF patients only);
- HF: New York Heart Association Functional Classification I to III (for COPD-HF patients only);
- Clinical stability for both diseases (COPD and/or HF) and no recent (within 3 months) exacerbation requiring a change in medications;
- Patient benefiting from health care coverage;
- Patient able to provide written informed consent.
Who cannot join
- Inability to perform cycle ergometry;
- Medical device incompatible with magnetic stimulation;
- Counter-indication to perform exercise test;
- Patient refusing to sign written informed consent;
- Patient not benefiting from health care coverage;
- Patient exceeding the annual ceiling of authorized compensation received following participation to a clinical trial;
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- Patient deprived of freedom by judicial or administrative decision;
- Patient subject to a measure of legal protection (safeguard of justice, guardianship, curatorship), who cannot be included in clinical trials;
- Pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)
Échirolles, Auvergne-Rhône-Alpes, 38130
Stéphane Doutreleau, MD, PhD, +33476765494, sdoutreleau@chu-grenoble.fr
Mathieu Marillier, PhD, +33681552231, mmarillier@chu-grenoble.fr
About this study
Official title: Impaired Tissue Oxygen Delivery in Patients With Coexistent COPD-heart Failure: What Consequences on Neuromuscular Fatigue During Exercise?
Rationale. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) coexist in approximately one third of patients presenting with one of these conditions. From a clinical standpoint, impaired tissue oxygen (O2) delivery stands as a common pathological mechanism of these cardiorespiratory diseases. Recent evidence suggest that muscle and cerebral blood flow and oxygenation are further impaired during exercise in patients with COPD-HF overlap compared to isolated diseases. However, it remains unknown whether impaired O2 delivery is associated with exaggerated manifestations of peripheral and central fatigue in COPD-HF overlap. In addition, improving cardiopulmonary interactions through non invasive positive pressure ventilation or through the addition of a hyperoxic gas mixture during exercise have been associated with enhanced cerebral and muscle O2 delivery and oxygenation in patients with COPD or HF. It is, therefore, conceivable that improved O2 delivery to these structures have beneficial influence on exercise capacity in patients with COPD-HF overlap due to less peripheral and central fatigue.
Aims. To investigate the influence of impaired O2 delivery during exercise, and its alleviation with different interventions (non invasive positive pressure ventilation or hyperoxia), on neuromuscular fatigue in patients with COPD-HF.
- Being tested
- Medical air, Hyperoxia
- Keywords
- Exercise Tolerance, Hypoxia, Brain, Muscle Fatigue, Oxygen, Spectroscopy, Near-Infrared, Ultrasonography, Doppler, Transcranial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical airOther
Exercise under medical air, both arms exposed.
HyperoxiaOther
Exercise under hyperoxia, only experimental arm exposed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Active comparator | Patients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF) Receives: Other: Medical air |
| Patients with COPD-HF overlap | Experimental | Patients with COPD-HF overlap will first exercise under medical air (for between-group comparison: COPD vs COPD-HF); Patients with COPD-HF overlap will then exercise under intervention (hyperoxia, for within-group comparison: medical air vs intervention trial) Receives: Other: Medical air; Other: Hyperoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fatigue
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
Measured: Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Secondary outcomes (4)
Exertional symptoms
Symptoms of dyspnea, leg discomfort, and fatigue
Measured: Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Tissue oxygenation
Prefrontal and quadriceps oxygenation (near-infrared spectroscopy)
Measured: Tissue oxygenation during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Cerebral blood flow
Middle cerebral artery blood flow velocity (transcranial Doppler ultrasonography)
Measured: Cerebral blood flow during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Cardiac output
Cardiac output (signal-morphology impedance cardiography)
Measured: Cardiac output during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start21 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 parralel study groups: patients with COPD (N=20); patients with COPD-HF overlap (N=20) Between-group comparison (COPD vs COPD-HF) under medical air Only patients with COPD-HF overlap exposed to intervention (hyperoxia)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Doutreleau, MD, PhD, Principal investigator, CHU Grenoble Alpes, Grenoble Alpes UniversityMathieu Marillier, PhD, Study chair, CHU Grenoble Alpes, Grenoble Alpes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235685
- Sponsor's protocol ID
- 2021-A02359-32
- Acronym
- FIBOX
- Status last verified
- Jun 2024
- First submitted
- 18 Jan 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request to the Investigators (unidentified patients' data).
Publications
Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.
PubMed 15860516Oliveira MF, Zelt JT, Jones JH, Hirai DM, O'Donnell DE, Verges S, Neder JA. Does impaired O2 delivery during exercise accentuate central and peripheral fatigue in patients with coexistent COPD-CHF? Front Physiol. 2015 Jan 7;5:514. doi: 10.3389/fphys.2014.00514. eCollection 2014.
PubMed 25610401Oliveira MF, Alencar MC, Arbex F, Souza A, Sperandio P, Medina L, Medeiros WM, Hirai DM, O'Donnell DE, Neder JA. Effects of heart failure on cerebral blood flow in COPD: Rest and exercise. Respir Physiol Neurobiol. 2016 Jan 15;221:41-8. doi: 10.1016/j.resp.2015.10.005. Epub 2015 Oct 31.
PubMed 26528895Oliveira MF, Arbex FF, Alencar MC, Souza A, Sperandio PA, Medeiros WM, Mazzuco A, Borghi-Silva A, Medina LA, Santos R, Hirai DM, Mancuso F, Almeida D, O'Donnell DE, Neder JA. Heart Failure Impairs Muscle Blood Flow and Endurance Exercise Tolerance in COPD. COPD. 2016 Aug;13(4):407-15. doi: 10.3109/15412555.2015.1117435. Epub 2016 Jan 20.
PubMed 26790095Borghi-Silva A, Oliveira CC, Carrascosa C, Maia J, Berton DC, Queiroga F Jr, Ferreira EM, Almeida DR, Nery LE, Neder JA. Respiratory muscle unloading improves leg muscle oxygenation during exercise in patients with COPD. Thorax. 2008 Oct;63(10):910-5. doi: 10.1136/thx.2007.090167. Epub 2008 May 20.
PubMed 18492743Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.
PubMed 18375714Oliveira MF, Rodrigues MK, Treptow E, Cunha TM, Ferreira EM, Neder JA. Effects of oxygen supplementation on cerebral oxygenation during exercise in chronic obstructive pulmonary disease patients not entitled to long-term oxygen therapy. Clin Physiol Funct Imaging. 2012 Jan;32(1):52-8. doi: 10.1111/j.1475-097X.2011.01054.x. Epub 2011 Oct 3.
PubMed 22152079
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Tissue Oxygen Delivery in Patients With Coexistent COPD-heart Failure: What Consequences on Neuromuscular Fatigue During Exercise?
- ClinicalTrials.gov ID
- NCT05235685
- Acronym / sponsor ID
- FIBOX / 2021-A02359-32
- Keywords
- Exercise Tolerance, Hypoxia, Brain, Muscle Fatigue, Oxygen, Spectroscopy, Near-Infrared, Ultrasonography, Doppler, Transcranial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Feb 2022 (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.
Rationale. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) coexist in approximately one third of patients presenting with one of these conditions. From a clinical standpoint, impaired tissue oxygen (O2) delivery stands as a common pathological mechanism of these cardiorespiratory diseases. Recent evidence suggest that muscle and cerebral blood flow and oxygenation are further impaired during exercise in patients with COPD-HF overlap compared to isolated diseases. However, it remains unknown whether impaired O2 delivery is associated with exaggerated manifestations of peripheral and central fatigue in COPD-HF overlap. In addition, improving cardiopulmonary interactions through non invasive positive pressure ventilation or through the addition of a hyperoxic gas mixture during exercise have been associated with enhanced cerebral and muscle O2 delivery and oxygenation in patients with COPD or HF. It is, therefore, conceivable that improved O2 delivery to these structures have beneficial influence on exercise capacity in patients with COPD-HF overlap due to less peripheral and central fatigue.
Aims. To investigate the influence of impaired O2 delivery during exercise, and its alleviation with different interventions (non invasive positive pressure ventilation or hyperoxia), on neuromuscular fatigue in patients with COPD-HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 parralel study groups: patients with COPD (N=20); patients with COPD-HF overlap (N=20) Between-group comparison (COPD vs COPD-HF) under medical air Only patients with COPD-HF overlap exposed to intervention (hyperoxia)
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | Active comparator | Other: Medical airPatients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF) |
| Patients with COPD-HF overlap | Experimental | Other: Medical air, Other: HyperoxiaPatients with COPD-HF overlap will first exercise under medical air (for between-group comparison: COPD vs COPD-HF); Patients with COPD-HF overlap will then exercise under intervention (hyperoxia, for within-group comparison: medical air vs intervention trial) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- COPD: mild-to-severe airflow obstruction (forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio <0.70; post-bronchodilator FEV1 > 30% predicted);
- HF: reduced left ventricular ejection fraction (<50%, for COPD-HF patients only);
- HF: New York Heart Association Functional Classification I to III (for COPD-HF patients only);
- Clinical stability for both diseases (COPD and/or HF) and no recent (within 3 months) exacerbation requiring a change in medications;
Key exclusion criteria (9 listed)
- Inability to perform cycle ergometry;
- Medical device incompatible with magnetic stimulation;
- Counter-indication to perform exercise test;
- Patient refusing to sign written informed consent;
- Patient not benefiting from health care coverage;
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 |
|---|---|---|
| Medical airExercise under medical air, both arms exposed. | Other | Patients with COPD, Patients with COPD-HF overlap |
| HyperoxiaExercise under hyperoxia, only experimental arm exposed. | Other | Patients with COPD-HF overlap |
Primary outcome
Muscle fatigue
Time frame: Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
4 secondary outcomes
Exertional symptoms
Time frame: Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Tissue oxygenation
Time frame: Tissue oxygenation during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Cerebral blood flow
Time frame: Cerebral blood flow during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Cardiac output
Time frame: Cardiac output during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 15860516Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.
- Background: PubMed 25610401Oliveira MF, Zelt JT, Jones JH, Hirai DM, O'Donnell DE, Verges S, Neder JA. Does impaired O2 delivery during exercise accentuate central and peripheral fatigue in patients with coexistent COPD-CHF? Front Physiol. 2015 Jan 7;5:514. doi: 10.3389/fphys.2014.00514. eCollection 2014.
- Background: PubMed 26528895Oliveira MF, Alencar MC, Arbex F, Souza A, Sperandio P, Medina L, Medeiros WM, Hirai DM, O'Donnell DE, Neder JA. Effects of heart failure on cerebral blood flow in COPD: Rest and exercise. Respir Physiol Neurobiol. 2016 Jan 15;221:41-8. doi: 10.1016/j.resp.2015.10.005. Epub 2015 Oct 31.
- Background: PubMed 26790095Oliveira MF, Arbex FF, Alencar MC, Souza A, Sperandio PA, Medeiros WM, Mazzuco A, Borghi-Silva A, Medina LA, Santos R, Hirai DM, Mancuso F, Almeida D, O'Donnell DE, Neder JA. Heart Failure Impairs Muscle Blood Flow and Endurance Exercise Tolerance in COPD. COPD. 2016 Aug;13(4):407-15. doi: 10.3109/15412555.2015.1117435. Epub 2016 Jan 20.
- Background: PubMed 18492743Borghi-Silva A, Oliveira CC, Carrascosa C, Maia J, Berton DC, Queiroga F Jr, Ferreira EM, Almeida DR, Nery LE, Neder JA. Respiratory muscle unloading improves leg muscle oxygenation during exercise in patients with COPD. Thorax. 2008 Oct;63(10):910-5. doi: 10.1136/thx.2007.090167. Epub 2008 May 20.
- Background: PubMed 18375714Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.
- Background: PubMed 22152079Oliveira MF, Rodrigues MK, Treptow E, Cunha TM, Ferreira EM, Neder JA. Effects of oxygen supplementation on cerebral oxygenation during exercise in chronic obstructive pulmonary disease patients not entitled to long-term oxygen therapy. Clin Physiol Funct Imaging. 2012 Jan;32(1):52-8. doi: 10.1111/j.1475-097X.2011.01054.x. Epub 2011 Oct 3.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request to the Investigators (unidentified patients' data).
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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.
Stéphane Doutreleau, MD, PhD principal investigator
CHU Grenoble Alpes, Grenoble Alpes University
Mathieu Marillier, PhD study chair
CHU Grenoble Alpes, Grenoble Alpes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical air and Hyperoxia in people with Pulmonary Disease, Chronic Obstructive and Heart Failure, run by University Hospital, Grenoble 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Doutreleau, MD, PhD (+33476767773, sdoutreleau@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fatigue (time frame: Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons). 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 NCT05235685, which also lists 7 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 24 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.