Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease

NCT ID: NCT04028973

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2023-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Fatigue is a prevalent symptom in Chronic Obstructive Pulmonary Disease (COPD) that limits patients in their daily living activities. It is now well established that COPD patients may have altered neuromuscular functions compared to healthy individuals. However, the different studies conducted on muscle fatigue in COPD have been done independently of any cognitive solicitation, yet present in most of daily living activities. Therefore, the aim of this research is to evaluate the impact of the disease on neuromuscular fatigue during dual-task situation (simultaneous accomplishment of a muscle contraction and a cognitive task). A better understanding of fatigue in COPD will promote the development of new perspectives in patient management.

The hypothesis is that COPD patients will exhibit increased fatigue level (compared to healthy subjects), particularly during dual-task situation. It is assumed that the higher negative effect associated with the dual-task will be related to different neurophysiological mechanisms (i.e., neuromuscular fatigue, autonomic nervous system activity, mental fatigue).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will include three experimental sessions for both COPD patients and healthy participants. These experimental sessions will be performed on three separate days. Each session will last between 1.5 and 2 hours.

The first session will correspond to a familiarization session with the different tests that will be performed during the two next sessions. During this first session, different functional tests will be also performed : 1-minute sit-to-stand tests and postural tests, with and without a concomitant cognitive task.

The second and third sessions will correspond to experimental sessions during which the participants will accomplish a fatiguing task in single or dual-task situation (randomized order). The cognitive task will be a memory cognitive task, called n-back task. The fatiguing tasks will involve submaximal isometric contractions of the knee extensors performed until task failure. The neuromuscular fatigue will be evaluated regularly during the fatiguing tasks (i.e. about each minute) using the magnetic stimulation of the femoral nerve in order to assess to central and peripheral determinants of the neuromuscular fatigue. Moreover, the autonomic nervous system activity (via cardiac recordings), perceived exertion and cognitive performance (in dual-task situation) will be continuously recorded during the fatiguing tasks. Before and after each fatiguing tasks, several questionnaires will be completed (i.e. mood, motivation, subjective workload) in order to evaluate the psychological determinants of performance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Evaluation of fatigue level in BPCO patients (condition 1)

Group Type EXPERIMENTAL

Single then dual task situation

Intervention Type OTHER

Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).

Evaluation of fatigue level in BPCO patients (condition 2)

Group Type EXPERIMENTAL

Dual then single task situation

Intervention Type OTHER

Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).

Evaluation of fatigue in control patients (condition 1)

Group Type ACTIVE_COMPARATOR

Single then dual task situation

Intervention Type OTHER

Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).

Evaluation of fatigue in control patients (condition 2)

Group Type ACTIVE_COMPARATOR

Dual then single task situation

Intervention Type OTHER

Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Single then dual task situation

Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).

Intervention Type OTHER

Dual then single task situation

Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

COPD patients :

* GOLD II - III or IV
* FEV1 \<80% of predicted values
* Men and women aged 40 years and over
* French-speaking participant
* BMI \<30 kg / m²
* Stable condition (i.e. without exacerbation) for more than 15 days
* Able to express their consent in writing prior to any participation in the study
* Affiliates or beneficiaries of a social security
* Minimum score of 26 on the MMSE questionnaire of 3 months or less

Healthy volunteers :

* Men and women aged 40 years and over
* French-speaking participant
* BMI \<30 kg / m²
* No known chronic respiratory, cardiovascular, metabolic, renal or neuromuscular pathologies
* Able to express their consent in writing prior to any participation in the study
* Affiliates or beneficiaries of a social security
* Minimum score of 26 on the MMSE questionnaire of 3 months or less

Exclusion Criteria

COPD patients :

* Alcoholism, i.e. \> 21 glasses a week for men and \>14 glasses a week for women
* Psychiatric pathologies or antecedent of behavioral disorders
* Patients treated with oral or systemic corticosteroids (\> 0.5 mg / kg / day for \> 7 days)
* Contraindication to the application of a magnetic field (i.e. right hip arthroplasty, pelvic / abdominal surgeries)
* Severe vision or hearing problems not corrected
* Patient oxygen dependent
* Patients in exclusion period from another research protocol
* Pregnant women (known pregnancy) or lactating women
* Patient deprived of liberty by a judicial or administrative decision
* Patient subject to a legal protection measure or unable to express their consent
* Patient who is not sufficiently fluent in reading and understanding the French language to be able to consent to participate in the study
* Patient unable to follow study procedures and to respect visits throughout the study period
* Person with a medical history that, in the opinion of the investigator, could interfere with the results of the study
* Any condition that, in the opinion of the investigator, could increase and compromise the safety of the person in the event that he / she participates in the study
* Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the aims of the study

Healthy volunteers:

* Alcoholism, i.e. \> 21 glasses a week for men and \>14 glasses a week for women
* Psychiatric pathologies or antecedent of behavioral disorders
* Patients treated with oral or systemic corticosteroids (\> 0.5 mg / kg / day for \> 7 days)
* Contraindication to the application of a magnetic field (i.e. right hip arthroplasty, pelvic / abdominal surgeries)
* Severe vision or hearing problems not corrected
* Subjects in exclusion period from another research protocol
* Pregnant women (known pregnancy) or lactating women
* Regular physical activity with a frequency greater than 3 sessions per week
* Participant deprived of liberty by a judicial or administrative decision
* Participant subject to a legal protection measure or unable to express their consent
* Participant who is not sufficiently fluent in reading and understanding the French language to be able to consent to participate in the study
* Participant unable to follow study procedures and to respect visits throughout the study period
* Person with a medical history that, in the opinion of the investigator, could interfere with the results of the study
* Any condition that, in the opinion of the investigator, could increase and compromise the safety of the person in the event that he / she participates in the study
* Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the aims of the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université de Toulon

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Marc VALLIER, MD PhD

Role: STUDY_DIRECTOR

Université de Toulon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Université de Toulon, laboratoires LAMHESS et IAPS

La Garde, Var, France

Site Status

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, Var, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Chatain C, Vallier JM, Paleiron N, Cucchietti Waltz F, Ramdani S, Gruet M. Muscle endurance, neuromuscular fatigability, and cognitive control during prolonged dual-task in people with chronic obstructive pulmonary disease: a case-control study. Eur J Appl Physiol. 2025 Feb;125(2):409-428. doi: 10.1007/s00421-024-05608-x. Epub 2024 Sep 21.

Reference Type RESULT
PMID: 39305368 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A01986-51

Identifier Type: OTHER

Identifier Source: secondary_id

2019-CHITS-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.