Neuromuscular Fatigue During Exercise in COPD-HF Overlap (FIBOX)

May 22, 2023 updated by: University Hospital, Grenoble

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

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 ± hyperoxia), on neuromuscular fatigue in patients with COPD-HF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Auvergne Rhône-Alpes
      • Echirolles, Auvergne Rhône-Alpes, France, 38130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • COPD: moderate-to-severe airflow obstruction (forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio <0.70; 30% ≤ post-bronchodilator FEV1 <80% 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with COPD
Patients with COPD will only exercise under medical air (for between-group comparison: COPD vs COPD-HF)
Other: Medical air
Exercise under medical air, both arms exposed.
Experimental: Patients with COPD-HF overlap
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 interventions (randomized order: non-invasive ventilation + medical air; non-invasive ventilation + hyperoxia, for within-group comparison: medical air vs intervention trials)
Other: Medical air
Exercise under medical air, both arms exposed.
Other: Non-invasive ventilation + Medical air
Exercise under non-invasive ventilation, only experimental arm exposed.
Other: Non-invasive ventilation + Hyperoxia
Exercise under non-invasive ventilation + hyperoxia, only experimental arm exposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle fatigue
Time Frame: Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
Muscle fatigue assessed immediately after exercise, between-group (COPD vs COPD-HF under medical air) and within-group (medical air vs intervention trials in COPD-HF) comparisons

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Study Chair: Mathieu Marillier, PhD, CHU Grenoble Alpes, Grenoble Alpes University
  • Principal Investigator: Stéphane Doutreleau, MD, PhD, CHU Grenoble Alpes, Grenoble Alpes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02359-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available on reasonable request to the Investigators (unidentified patients' data).

IPD Sharing Time Frame

Data will be available on reasonable request to the Investigators (unidentified patients' data) upon study completion and for an unrestricted period of time.

IPD Sharing Access Criteria

Data available on reasonable request to the Investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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