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Neuromuscular Fatigue During Exercise in COPD-HF Overlap (FIBOX)

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Medical air

Non-invasive ventilation + Medical air

Non-invasive ventilation + Hyperoxia

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exercise Tolerance, Hypoxia, Brain, Muscle Fatigue, Oxygen, Spectroscopy, Near-Infrared, Ultrasonography, Doppler, Transcranial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patients with COPD

Patients with COPD-HF overlap

Arm Description

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

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 interventions (randomized order: non-invasive ventilation + medical air; non-invasive ventilation + hyperoxia, for within-group comparison: medical air vs intervention trials)

Outcomes

Primary Outcome Measures

Muscle fatigue

Muscle fatigue assessed by magnetic stimulation of the femoral nerve

Secondary Outcome Measures

Exertional symptoms

Symptoms of dyspnea, leg discomfort, and fatigue

Tissue oxygenation

Prefrontal and quadriceps oxygenation (near-infrared spectroscopy)

Cerebral blood flow

Middle cerebral artery blood flow velocity (transcranial Doppler ultrasonography)

Cardiac output

Cardiac output (signal-morphology impedance cardiography)

Full Information

NCT ID

NCT05235685

First Posted

January 18, 2022

Last Updated

May 22, 2023

Sponsor

University Hospital, Grenoble

1. Study Identification

Unique Protocol Identification Number

NCT05235685

Brief Title

Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Acronym

FIBOX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 21, 2023 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Heart Failure

Keywords

Exercise Tolerance, Hypoxia, Brain, Muscle Fatigue, Oxygen, Spectroscopy, Near-Infrared, Ultrasonography, Doppler, Transcranial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 interventions (non-invasive ventilation + medical air; non-invasive ventilation + hyperoxia)

Masking

Participant

Masking Description

Patients masked from interventions (non-invasive ventilation and gas mixture being delivered) Allocation: allocation to non-invasive ventilation + medical air; non-invasive ventilation + hyperoxia = randomized in patients with COPD-HF overlap

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with COPD

Arm Type

Active Comparator

Arm Description

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

Arm Title

Patients with COPD-HF overlap

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Medical air

Intervention Description

Exercise under medical air, both arms exposed.

Intervention Type

Other

Intervention Name(s)

Non-invasive ventilation + Medical air

Intervention Description

Exercise under non-invasive ventilation, only experimental arm exposed.

Intervention Type

Other

Intervention Name(s)

Non-invasive ventilation + Hyperoxia

Intervention Description

Exercise under non-invasive ventilation + hyperoxia, only experimental arm exposed.

Primary Outcome Measure Information:

Title

Muscle fatigue

Description

Muscle fatigue assessed by magnetic stimulation of the femoral nerve

Time Frame

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 Outcome Measure Information:

Title

Exertional symptoms

Description

Symptoms of dyspnea, leg discomfort, and fatigue

Time Frame

Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons

Title

Tissue oxygenation

Description

Prefrontal and quadriceps oxygenation (near-infrared spectroscopy)

Time Frame

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

Title

Cerebral blood flow

Description

Middle cerebral artery blood flow velocity (transcranial Doppler ultrasonography)

Time Frame

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

Title

Cardiac output

Description

Cardiac output (signal-morphology impedance cardiography)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphane Doutreleau, MD, PhD

Phone

+33476767773

sdoutreleau@chu-grenoble.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Mathieu Marillier, PhD

Phone

+33681552231

mmarillier@chu-grenoble.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphane Doutreleau, MD, PhD

Organizational Affiliation

CHU Grenoble Alpes, Grenoble Alpes University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mathieu Marillier, PhD

Organizational Affiliation

CHU Grenoble Alpes, Grenoble Alpes University

Official's Role

Study Chair

Facility Information:

Facility Name

CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)

City

Echirolles

State/Province

Auvergne Rhône-Alpes

ZIP/Postal Code

38130

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane Doutreleau, MD, PhD

Phone

+33476765494

sdoutreleau@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Mathieu Marillier, PhD

Phone

+33681552231

mmarillier@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be available on reasonable request to the Investigators (unidentified patients' data).

IPD Sharing Time Frame

Data will be available on reasonable request to the Investigators (unidentified patients' data) upon study completion and for an unrestricted period of time.

IPD Sharing Access Criteria

Data available on reasonable request to the Investigators.

Citations:

PubMed Identifier

15860516

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.

Results Reference

background

PubMed Identifier

25610401

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.

Results Reference

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PubMed Identifier

26528895

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.

Results Reference

background

PubMed Identifier

26790095

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.

Results Reference

background

PubMed Identifier

18492743

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.

Results Reference

background

PubMed Identifier

18375714

Citation

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.

Results Reference

background

PubMed Identifier

22152079

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.

Results Reference

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Neuromuscular Fatigue During Exercise in COPD-HF Overlap

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