Status:

RECRUITING

Neuromuscular Fatigue During Exercise in COPD-HF Overlap

Lead Sponsor:

University Hospital, Grenoble

Conditions:

Pulmonary Disease, Chronic Obstructive

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

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, impai...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 21 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05235685

Start Date

February 21 2023

End Date

December 1 2025

Last Update

June 24 2024

Active Locations (1)

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1

CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)

Échirolles, Auvergne-Rhône-Alpes, France, 38130