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Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease (NEUROTIGUE)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single then dual task situation
Dual then single task situation
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Neuromuscular fatigue, Muscle, Dual-task, Mental fatigue

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Université de Toulon, laboratoires LAMHESS et IAPS
  • Hôpital d'Instruction des Armées Sainte-Anne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Evaluation of fatigue level in BPCO patients (condition 1)

Evaluation of fatigue level in BPCO patients (condition 2)

Evaluation of fatigue in control patients (condition 1)

Evaluation of fatigue in control patients (condition 2)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Autonomic nervous system activity
Autonomic nervous system activity will be continuously recorded during the fatiguing tasks using cardiac measurements .
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.
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.

Full Information

First Posted
July 19, 2019
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Université de Toulon
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1. Study Identification

Unique Protocol Identification Number
NCT04028973
Brief Title
Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease
Acronym
NEUROTIGUE
Official Title
Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Université de Toulon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Neuromuscular fatigue, Muscle, Dual-task, Mental fatigue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of fatigue level in BPCO patients (condition 1)
Arm Type
Experimental
Arm Title
Evaluation of fatigue level in BPCO patients (condition 2)
Arm Type
Experimental
Arm Title
Evaluation of fatigue in control patients (condition 1)
Arm Type
Active Comparator
Arm Title
Evaluation of fatigue in control patients (condition 2)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Single then dual task situation
Intervention Description
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
Intervention Name(s)
Dual then single task situation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Endurance time differences between simple and dual-task conditions, in COPD patients compared to healthy participants
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Neuromuscular fatigue of knee extensors
Description
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.
Time Frame
About each minute during the fatiguing tasks lasting about 20 minutes
Title
Autonomic nervous system activity
Description
Autonomic nervous system activity will be continuously recorded during the fatiguing tasks using cardiac measurements .
Time Frame
Continuously during the fatiguing tasks lasting about 20 minutes
Title
Mental fatigue
Description
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.
Time Frame
Continuously during the fatiguing task in dual-task condition, which should last about 20 minutes
Title
Psychological state
Description
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.
Time Frame
Before, during and after fatiguing task lasting about 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc VALLIER, MD PhD
Organizational Affiliation
Université de Toulon
Official's Role
Study Director
Facility Information:
Facility Name
Université de Toulon, laboratoires LAMHESS et IAPS
City
La Garde
State/Province
Var
ZIP/Postal Code
83130
Country
France
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
State/Province
Var
ZIP/Postal Code
83000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease

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