Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Heart Failure Clinical Trial

— FIBOX  

Official title:

Impaired Tissue Oxygen Delivery in Patients With Coexistent COPD-heart Failure: What Consequences on Neuromuscular Fatigue During Exercise?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235685
• Other study ID #: 2021-A02359-32
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: Stéphane Doutreleau, MD, PhD
• Phone: +33476767773
• Email: sdoutreleau[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 ± hyperoxia), on neuromuscular fatigue in patients with COPD-HF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years;
• COPD: moderate-to-severe airflow obstruction (forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio <0.70; 30% = post-bronchodilator FEV1 <80% 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.

Exclusion Criteria:

• 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;
• 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.

Related Conditions & MeSH terms

• Fatigue
• Heart Failure
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Medical air
Exercise under medical air, both arms exposed.
• Non-invasive ventilation + Medical air
Exercise under non-invasive ventilation, only experimental arm exposed.
• Non-invasive ventilation + Hyperoxia
Exercise under non-invasive ventilation + hyperoxia, only experimental arm exposed.

Locations

Country	Name	City	State
France	CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)	Echirolles	Auvergne Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

Borghi-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. — View Citation

Borghi-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. — View Citation

Oliveira 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. — View Citation

Oliveira 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. — View Citation

Oliveira 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. — View Citation

Oliveira 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle fatigue	Muscle fatigue assessed by magnetic stimulation of the femoral nerve	Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons
Secondary	Exertional symptoms	Symptoms of dyspnea, leg discomfort, and fatigue	Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons
Secondary	Tissue oxygenation	Prefrontal and quadriceps oxygenation (near-infrared spectroscopy)	Tissue oxygenation during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons
Secondary	Cerebral blood flow	Middle cerebral artery blood flow velocity (transcranial Doppler ultrasonography)	Cerebral blood flow during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons
Secondary	Cardiac output	Cardiac output (signal-morphology impedance cardiography)	Cardiac output during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons