FIBOX: Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05235685

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive Heart Failure	Other: Medical air Other: Non-invasive ventilation + Medical air Other: Non-invasive ventilation + Hyperoxia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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:

Single (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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients with COPD Patients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF)	Other: Medical air Exercise under medical air, both arms exposed.
Experimental: 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 interventions (randomized order: non-invasive ventilation + medical air; non-invasive ventilation + hyperoxia, for within-group comparison: medical air vs intervention trials)	Other: Medical air Exercise under medical air, both arms exposed. Other: Non-invasive ventilation + Medical air Exercise under non-invasive ventilation, only experimental arm exposed. Other: Non-invasive ventilation + Hyperoxia Exercise under non-invasive ventilation + hyperoxia, only experimental arm exposed.

Arm

Intervention/Treatment

Active Comparator: Patients with COPD

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

Other: Medical air

Exercise under medical air, both arms exposed.

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

Other: Medical air

Exercise under medical air, both arms exposed.

Other: Non-invasive ventilation + Medical air

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

Other: Non-invasive ventilation + Hyperoxia

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

Outcome Measures

Primary Outcome Measures

Muscle fatigue [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]
Muscle fatigue assessed by magnetic stimulation of the femoral nerve

Secondary Outcome Measures

Exertional symptoms [Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons]
Symptoms of dyspnea, leg discomfort, and fatigue
Tissue oxygenation [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]
Prefrontal and quadriceps oxygenation (near-infrared spectroscopy)
Cerebral blood flow [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]
Middle cerebral artery blood flow velocity (transcranial Doppler ultrasonography)
Cardiac output [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]
Cardiac output (signal-morphology impedance cardiography)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Stéphane Doutreleau, MD, PhD, CHU Grenoble Alpes, Grenoble Alpes University
Study Chair: Mathieu Marillier, PhD, CHU Grenoble Alpes, Grenoble Alpes University