Examining muscle fatigue during exercise in patients with COPD and heart failure

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

This study is testing if giving extra oxygen during exercise can help people with both COPD and heart failure feel less tired and improve their ability to exercise.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Grenoble (Academic / other)
• Locations: 1 site (Échirolles, Auvergne-Rhône-Alpes)
• Trial ID: NCT05235685 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between impaired oxygen delivery and muscle and brain fatigue during exercise in patients with overlapping chronic obstructive pulmonary disease (COPD) and heart failure (HF). It aims to determine whether enhanced oxygen delivery through non-invasive ventilation or hyperoxic gas mixtures can alleviate fatigue symptoms in these patients. The study will involve assessing exercise tolerance and oxygenation levels using advanced techniques such as near-infrared spectroscopy. By understanding these dynamics, the research seeks to improve treatment strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable COPD and heart failure, specifically those with reduced left ventricular ejection fraction.

Not a fit: Patients who are unable to perform exercise tests or have contraindications to exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved exercise tolerance and quality of life for patients suffering from both COPD and heart failure.

How similar studies have performed: Other studies have shown promising results in improving oxygen delivery and exercise capacity in patients with COPD and heart failure, suggesting that this approach may be effective.

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.

Where this trial is running

Échirolles, Auvergne-Rhône-Alpes

• CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2) — Échirolles, Auvergne-Rhône-Alpes, France (Recruiting)

Study contacts

• Principal investigator: Stéphane Doutreleau, MD, PhD — CHU Grenoble Alpes, Grenoble Alpes University
• Study coordinator: Stéphane Doutreleau, MD, PhD

Conditions Pulmonary Disease, Chronic Obstructive; Heart Failure; Exercise Tolerance; Hypoxia, Brain; Muscle Fatigue; Oxygen; Spectroscopy, Near-Infrared; Ultrasonography, Doppler, Transcranial