Chronic Obstructive Pulmonary Disease (COPD)NEUROTIGUENCT04028973
Neuromuscular Fatigue in Chronic Obstructive Pulonary Disease
A study testing Single then dual task situation and Dual then single task situation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Single then dual task situation and Dual then single task situation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Sep 2020to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Université de Toulon, laboratoires LAMHESS et IAPS
La Garde, Var, 83130
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, Var, 83000
About this study
Official title: Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)
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).
Read the 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.
- Being tested
- Single then dual task situation, Dual then single task situation
- Keywords
- COPD, Neuromuscular fatigue, Muscle, Dual-task, Mental fatigue
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single then dual task situationOther
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 situationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of fatigue level in BPCO patients (condition 1) | Experimental | Not described Receives: Other: Single then dual task situation |
| Evaluation of fatigue level in BPCO patients (condition 2) | Experimental | Not described Receives: Other: Dual then single task situation |
| Evaluation of fatigue in control patients (condition 1) | Active comparator | Not described Receives: Other: Single then dual task situation |
| Evaluation of fatigue in control patients (condition 2) | Active comparator | Not described Receives: Other: Dual then single task situation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: About each minute during the fatiguing tasks lasting about 20 minutes
Autonomic nervous system activity
Autonomic nervous system activity will be continuously recorded during the fatiguing tasks using cardiac measurements .
Measured: Continuously during the fatiguing tasks lasting about 20 minutes
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.
Measured: Continuously during the fatiguing task in dual-task condition, which should last about 20 minutes
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.
Measured: Before, during and after fatiguing task lasting about 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start16 Sep 2020
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Toulon
- Responsible party
- Sponsor
- Investigators
- Jean-Marc VALLIER, MD PhD, Study director, Université de Toulon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028973
- Sponsor's protocol ID
- 2019-CHITS-03
- Other IDs
- 2019-A01986-51
- Acronym
- NEUROTIGUE
- Status last verified
- Jan 2025
- First submitted
- 19 Jul 2019
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39305368
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04028973
- Acronym / sponsor ID
- NEUROTIGUE / 2019-CHITS-03
- Keywords
- COPD, Neuromuscular fatigue, Muscle, Dual-task, Mental fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Université de Toulon
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single then dual task situationFirstly, 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). | Other | Evaluation of fatigue in control patients (condition 1), Evaluation of fatigue level in BPCO patients (condition 1) |
| Dual then single task situationFirstly, 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). | Other | Evaluation of fatigue in control patients (condition 2), Evaluation of fatigue level in BPCO patients (condition 2) |
Primary outcome
Endurance time differences between simple and dual-task conditions, in COPD patients compared to healthy participants
Time frame: 7 days
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.
4 secondary outcomes
Neuromuscular fatigue of knee extensors
Time frame: About each minute during the fatiguing tasks lasting about 20 minutes
Autonomic nervous system activity
Time frame: Continuously during the fatiguing tasks lasting about 20 minutes
Mental fatigue
Time frame: Continuously during the fatiguing task in dual-task condition, which should last about 20 minutes
Psychological state
Time frame: Before, during and after fatiguing task lasting about 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 39305368Chatain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc VALLIER, MD PhD study director
Université de Toulon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single then dual task situation and Dual then single task situation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time differences between simple and dual-task conditions, in COPD patients compared to healthy participants (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.