Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Not Applicable

Recruiting

• Conditions: Heart Failure; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Medical air; Other: Hyperoxia

• Registration Number: NCT05235685
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Study Start: 2023-02-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with COPD-HF overlap	Hyperoxia	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)
Patients with COPD	Medical air	Patients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF)
Patients with COPD-HF overlap	Medical air	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)

Primary Outcome Measures

Name	Time	Method
Muscle fatigue	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	Muscle fatigue assessed by magnetic stimulation of the femoral nerve

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2); 🇫🇷 Echirolles, Auvergne Rhône-Alpes, France