Clinical trial NCT05235685: Neuromuscular Fatigue During Exercise in COPD-HF Overlap
Official title: Impaired Tissue Oxygen Delivery in Patients With Coexistent COPD-heart Failure: What Consequences on Neuromuscular Fatigue During Exercise?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Heart Failure
Keywords: Exercise Tolerance
Hypoxia, Brain
Muscle Fatigue
Oxygen
Spectroscopy, Near-Infrared
Ultrasonography, Doppler, Transcranial
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 intervention (hyperoxia)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Muscle fatigue
timeFrame: 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:
measure: Exertional symptoms
timeFrame: Symptoms during exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trial in COPD-HF) comparisons
measure: Tissue oxygenation
timeFrame: 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
measure: Cerebral blood flow
timeFrame: 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
measure: Cardiac output
timeFrame: 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
Other outcomes:
Locations:
city: Echirolles
country: France
facility: CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)
state: Auvergne Rhône-Alpes
Study officials:
affiliation: CHU Grenoble Alpes, Grenoble Alpes University
name: Stéphane Doutreleau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Grenoble Alpes, Grenoble Alpes University
name: Mathieu Marillier, PhD
role: STUDY_CHAIR
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