Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease

NCT04028973 | Completed

• 2 other identifiers: 2019-CHITS-032019-A01986-51
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Neuromuscular fatigue; Muscle; Dual-task; Mental fatigue

Outcome Measures

Primary Outcomes (1)

• Endurance time differences between simple and dual-task conditions, in COPD patients compared to healthy participants

  The endurance times will correspond to the duration of the fatiguing tasks (simple and dual-task). The endurance time differences between simple and dual-task conditions will be calculated as follows : Endurance time in simple task condition - Endurance time in dual-task condition = Difference of endurance time.

  7 days

Secondary Outcomes (4)

• Neuromuscular fatigue of knee extensors

  About each minute during the fatiguing tasks lasting about 20 minutes

• Autonomic nervous system activity

  Continuously during the fatiguing tasks lasting about 20 minutes

• Mental fatigue

  Continuously during the fatiguing task in dual-task condition, which should last about 20 minutes

• Psychological state

  Before, during and after fatiguing task lasting about 20 minutes

Study Arms (4)

Evaluation of fatigue level in BPCO patients (condition 1)

EXPERIMENTAL

Other: Single then dual task situation

Evaluation of fatigue level in BPCO patients (condition 2)

EXPERIMENTAL

Other: Dual then single task situation

Evaluation of fatigue in control patients (condition 1)

ACTIVE COMPARATOR

Other: Single then dual task situation

Evaluation of fatigue in control patients (condition 2)

ACTIVE COMPARATOR

Other: Dual then single task situation

Interventions

Single then dual task situation 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 1); Evaluation of fatigue level in BPCO patients (condition 1)

Dual then single task situation 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 2); Evaluation of fatigue level in BPCO patients (condition 2)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Université de Toulon: collaborator

Study Sites (2)

Université de Toulon, laboratoires LAMHESS et IAPS

La Garde, Var, 83130, France

Location

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, Var, 83000, France

Location

Related Publications (1)

• 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.

  PMID: 39305368 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Mental Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Jean-Marc VALLIER, MD PhD

  Université de Toulon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: September 16, 2020
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)