Neuromuscular Fatigue During Exercise in COPD-HF Overlap (NCT05235685) | Clinical Trial Compass
RecruitingNot Applicable
Neuromuscular Fatigue During Exercise in COPD-HF Overlap
France40 participantsStarted 2023-02-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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