Chronic Obstructive Pulmonary Disease (COPD)NEUROTIGUE FNCT06871670
Force Control in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Maximal muscle strength is one of the most commonly assessed neuromuscular parameters in people with COPD due to its accessibility and relevance for prescribing an appropriate workload for resistance training. 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?
- Submaximal isometric contractions of knee extensors
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2025to 8 Mar 2025
- Phase
- Observational
- 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
Study population: Participants enrolled in NEUROTIGUE study (NCT04028973)
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
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- 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
- For all participants :
- -Subject who has not objected to the reuse of data collected
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
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- 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
1 site in 1 country.
France1 site
Université de Toulon, laboratoires Laboratoire J-AP2S
Toulon, VAR, 83000
About this study
Official title: Knee Extensors Force Control in People With Chronic Obstructive Pulmonary Disease
Maximal muscle strength is one of the most commonly assessed neuromuscular parameters in people with COPD due to its accessibility and relevance for prescribing an appropriate workload for resistance training. However, maximal force production is very rarely necessary during daily activities which requires production of submaximal and precisely controlled forces. Despite growing research on motor impairments in COPD, very little attention has been given to the effect of this disease on force control. Therefore, this research aims to better understand the potential deficits in force control caused by COPD, through the use of advanced signal processing methods (i.e., nonlinear approaches). We hypothesized that force control would be reduced in people with COPD compared to healthy individuals, particularly at low force levels.
Read the detailed description
This observational study is based on the analyses of data (force signals) recorded during the first visit of NEUROTIGUE study (NCT04028973).
Force signals were recorded during brief submaximal isometric contractions of the knee extensors performed by both COPD patients and healthy individuals. Each participant performed contractions at different intensity of his/her maximal muscle strength : 10, 20, 30, 40, 50 and 60%. Two contractions of approximately 6s duration were performed at each intensity by all participants. For a given intensity (e.g., 10%), both contractions were performed in a row but different intensities were accomplished in a random order.
Force control will be assess using a conjunction of parameters to provide a comprehensive understanding of force variability (e.g., coefficient of variation, non-linear approaches).
- Being tested
- Submaximal isometric contractions of knee extensors
- Keywords
- COPD, Muscle, Force control, Non-linear, Variability, Isometric contractions
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submaximal isometric contractions of knee extensorsOther
Brief isometric contractions performed at 10, 20, 30, 40, 50 and 60% of maximal voluntary force in a random order.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Patients with chronic obstructive pulmonary disease Receives: Other: Submaximal isometric contractions of knee extensors | |
| Control participants | Healthy individuals Receives: Other: Submaximal isometric contractions of knee extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the coefficient of variation (CV) of force signal between COPD patients and healthy participants for different contraction intensities.
CV (%) is calculated as the ratio between standard deviation (SD) of force signal during muscle contraction and the mean produced force during the contraction.
Measured: 10-min
Secondary outcomes (3)
Difference of the root mean square error (RMSE) of force signal between COPD patients and healthy participants for different contraction intensities.
RMSE (%) is calculated as the absolute difference between the average produced force and the target force expressed as a percentage of the target.
Measured: 10-min
Difference of Sample Entropy (SampEn) of force signal between COPD patients and healthy participants for different contraction intensities.
SampEn is a non-linear approach allowing to quantify the regularity of force signal.
Measured: 10-min
Difference of Determinism (DET) from Recurrence Quantification Analysis (RQA) of force signal between COPD patients and healthy participants for different contraction intensities
DET from RQA represent another non-linear approach allowing to assess the regularity of force signal.
Measured: 10-min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start7 Mar 2025
- Primary completion8 Mar 2025
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- 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
- NCT06871670
- Sponsor's protocol ID
- 2025-CHITS-005
- Acronym
- NEUROTIGUE F
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Extensors Force Control in People With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06871670
- Acronym / sponsor ID
- NEUROTIGUE F / 2025-CHITS-005
- Keywords
- COPD, Muscle, Force control, Non-linear, Variability, Isometric contractions
- Study type
- Observational
- 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
- 7 Mar 2025 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 12 Mar 2025 (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.
Maximal muscle strength is one of the most commonly assessed neuromuscular parameters in people with COPD due to its accessibility and relevance for prescribing an appropriate workload for resistance training. However, maximal force production is very rarely necessary during daily activities which requires production of submaximal and precisely controlled forces. Despite growing research on motor impairments in COPD, very little attention has been given to the effect of this disease on force control. Therefore, this research aims to better understand the potential deficits in force control caused by COPD, through the use of advanced signal processing methods (i.e., nonlinear approaches). We hypothesized that force control would be reduced in people with COPD compared to healthy individuals, particularly at low force levels.
Detailed description
This observational study is based on the analyses of data (force signals) recorded during the first visit of NEUROTIGUE study (NCT04028973).
Force signals were recorded during brief submaximal isometric contractions of the knee extensors performed by both COPD patients and healthy individuals. Each participant performed contractions at different intensity of his/her maximal muscle strength : 10, 20, 30, 40, 50 and 60%. Two contractions of approximately 6s duration were performed at each intensity by all participants. For a given intensity (e.g., 10%), both contractions were performed in a row but different intensities were accomplished in a random order.
Force control will be assess using a conjunction of parameters to provide a comprehensive understanding of force variability (e.g., coefficient of variation, non-linear approaches).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | Other: Submaximal isometric contractions of knee extensorsPatients with chronic obstructive pulmonary disease |
| Control participants | – | Other: Submaximal isometric contractions of knee extensorsHealthy individuals |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants enrolled in NEUROTIGUE study (NCT04028973)
Key inclusion criteria (20 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 |
|---|---|---|
| Submaximal isometric contractions of knee extensorsBrief isometric contractions performed at 10, 20, 30, 40, 50 and 60% of maximal voluntary force in a random order. | Other | Control participants, Patients with COPD |
Primary outcome
Difference of the coefficient of variation (CV) of force signal between COPD patients and healthy participants for different contraction intensities.
Time frame: 10-min
CV (%) is calculated as the ratio between standard deviation (SD) of force signal during muscle contraction and the mean produced force during the contraction.
3 secondary outcomes
Difference of the root mean square error (RMSE) of force signal between COPD patients and healthy participants for different contraction intensities.
Time frame: 10-min
Difference of Sample Entropy (SampEn) of force signal between COPD patients and healthy participants for different contraction intensities.
Time frame: 10-min
Difference of Determinism (DET) from Recurrence Quantification Analysis (RQA) of force signal between COPD patients and healthy participants for different contraction intensities
Time frame: 10-min
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site 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 20 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Difference of the coefficient of variation (CV) of force signal between COPD patients and healthy participants for different contraction intensities. (time frame: 10-min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.