Neuromuscular Fatigue During Exercise in COPD-HF Overlap
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Inability to perform cycle ergometry;
Medical device incompatible with magnetic stimulation;
Counter-indication to perform exercise test;
Patient refusing to sign written informed consent;
Trial design
Design model
Parallel
Treatments tested in this trial
Medical air
Other interventionExercise under medical air, both arms exposed.
Hyperoxia
Other interventionExercise under hyperoxia, only experimental arm exposed.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Patients with COPDActive comparator 1 intervention
Group B: Patients with COPD-HF overlapExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Muscle fatigue
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 trial in COPD-HF) comparisonsSecondary outcomes
1
Exertional symptoms
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 trial in COPD-HF) comparisons2
Tissue oxygenation
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 trial in COPD-HF) comparisons3
Cerebral blood flow
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 trial in COPD-HF) comparisons4
Cardiac output
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 trial in COPD-HF) comparisonsSponsors and contacts
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Source ClinicalTrials.gov