Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— NEUROTIGUE  

Official title:

Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028973
• Other study ID #: 2019-CHITS-03
• Secondary ID: 2019-A01986-51
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: February 17, 2023

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Fatigue
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
France	Université de Toulon, laboratoires LAMHESS et IAPS	La Garde	Var
France	Hôpital d'Instruction des Armées Sainte-Anne	Toulon	Var

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Université de Toulon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neuromuscular fatigue of knee extensors	The neuromuscular fatigue will be evaluated regularly during the fatiguing tasks using the magnetic stimulation of the femoral nerve , during and after maximal voluntary contraction. Moreover, the muscle activity of the Vastus Lateralis, using non-invasive surface electromyography (sEMG), will be continuously recorded during the fatiguing tasks.	About each minute during the fatiguing tasks lasting about 20 minutes
Secondary	Autonomic nervous system activity	Autonomic nervous system activity will be continuously recorded during the fatiguing tasks using cardiac measurements .	Continuously during the fatiguing tasks lasting about 20 minutes
Secondary	Mental fatigue	The influence of mental fatigue on the performance will be assessed using the cognitive performance (i.e. rate of correct answers and reaction time) that will be continuously recorded during fatiguing dual-task.	Continuously during the fatiguing task in dual-task condition, which should last about 20 minutes
Secondary	Psychological state	Psychology influence on task performance will be evaluated with questionnaires before, during and after the task. For motivation: 14 items, scores from 0 (not at all) to 4 (extremely), 2 subscales assessing intrinsic and success-based motivation (scores from 0 to 28). For mood: 24 adjectives, scores from 0 (not at all) to 4 (extremely), 6 subscales evaluating fatigue, confusion, vigor, depression, tension and anger (scores from 0 to 16). For Rating-of-Fatigue scale: one score from 0 (not tired) to 10 (exhaustion). For dyspnea: one score from 0 (nothing) to 10 (extremely strong). For Task Load Index: 6 subscales, from 0 (very low) to 20 (very high), measure mental and physical difficulties, time pressure, performance perception, effort perception and frustration. For Sleep Quality Index: 24 questions, 7 subscales from 0 to 3 evaluating subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medication and day dysfunction due to sleepiness.	Before, during and after fatiguing task lasting about 20 minutes