Neuromuscular Fatigue During Exercise in COPD-HF Overlap

NCT ID: NCT05235685

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2025-12-31

Brief 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 or hyperoxia), on neuromuscular fatigue in patients with COPD-HF.

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients with COPD

Patients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF)

Group Type: ACTIVE_COMPARATOR

Medical air

Intervention Type: OTHER

Exercise under medical air, both arms exposed.

Patients with COPD-HF overlap

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)

Group Type: EXPERIMENTAL

Medical air

Intervention Type: OTHER

Exercise under medical air, both arms exposed.

Hyperoxia

Intervention Type: OTHER

Exercise under hyperoxia, only experimental arm exposed.

Interventions

Medical air

Exercise under medical air, both arms exposed.

Intervention Type: OTHER

Hyperoxia

Exercise under hyperoxia, only experimental arm exposed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane Doutreleau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes, Grenoble Alpes University

Mathieu Marillier, PhD

Role: STUDY_CHAIR

CHU Grenoble Alpes, Grenoble Alpes University

Locations

CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)

Échirolles, Auvergne-Rhône-Alpes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane Doutreleau, MD, PhD

Role: CONTACT

sdoutreleau@chu-grenoble.fr

+33476767773

Mathieu Marillier, PhD

Role: CONTACT

mmarillier@chu-grenoble.fr

+33681552231

Facility Contacts

Stéphane Doutreleau, MD, PhD

Role: primary

sdoutreleau@chu-grenoble.fr

+33476765494

Mathieu Marillier, PhD

Role: backup

mmarillier@chu-grenoble.fr

+33681552231

References

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.

Reference Type: BACKGROUND

PMID: 15860516 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25610401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26528895 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26790095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18492743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18375714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22152079 (View on PubMed)

Other Identifiers

2021-A02359-32

Identifier Type: -

Identifier Source: org_study_id