Chronic Obstructive Pulmonary Disease (COPD)NEUROTIGUE PNCT06863246
Postural 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
Postural control impairment is common in people with COPD (pwCOPD), which can increase the risk of falls and affect quality of life. However, the majority of existing studies examine this postural control in isolation, without taking into account the cognitive demands that occur during activities of daily living… 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?
- Evaluation of cognitive task on static balance and Evaluation of visual feedback on static balance
- 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.
About this study
Official title: Influence of Cognitive Load on Postural Control in People With Chronic Obstructive Pulmonary Disease
Postural control impairment is common in people with COPD (pwCOPD), which can increase the risk of falls and affect quality of life. However, the majority of existing studies examine this postural control in isolation, without taking into account the cognitive demands that occur during activities of daily living during which individuals are often required to perform a mental task while maintaining their balance. This research aims to fill this gap by studying how a cognitive task can influence postural control in pwCOPD. We hypothesized an impaired postural control in pwCOPD compared to healthy individuals, which would be exacerbated in presence of a cognitive task.
Read the detailed description
This observational study is based on the analyses of data (center of pressure displacement) recorded during the first visit of NEUROTIGUE study (NCT04028973).
Center of pressure (COP) displacement were recorded during 60s of static balance in four conditions (random order) :
- Eyes open without cognitive task
- Eyes open with cognitive task
- Eyes closed without cognitive task
- Eyes closed with cognitive task The cognitive task used was a working memory task : the 1-back task. COP displacement will be assess using a conjunction of parameters to provide a comprehensive understanding of postural control (e.g., amplitude, standard deviation, non-linear approaches).
- Being tested
- Evaluation of cognitive task on static balance, Evaluation of visual feedback on static balance
- Keywords
- COPD, Postural control, Variability, Non-linear, Cognitive task, Static balance
- 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.
Evaluation of cognitive task on static balanceOther
Static balance with and without cognitive task (i.e., 1-back task)
Evaluation of visual feedback on static balanceOther
Static balance with and without visual feedback (i.e., eyes closed and open).
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Patients with chronic obstructive pulmonary disease Receives: Other: Evaluation of cognitive task on static balance; Other: Evaluation of visual feedback on static balance | |
| Control participants | Healthy individuals Receives: Other: Evaluation of cognitive task on static balance; Other: Evaluation of visual feedback on static balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the range of COP displacement between groups and experimental conditions
Range of COP displacement correspond to the maximal amplitude of the path of COP in anteroposterior and mediolateral directions.
Measured: 10 minutes
Secondary outcomes (3)
Difference of Sample Entropy (SampEn) of COP displacement between groups and experimental conditions
SampEn is a non-linear approach allowing to quantify the regularity of COP displacement in anteroposterior and mediolateral directions.
Measured: 10 minutes
Difference of total COP displacement between groups and experimental conditions
The total COP displacement corresponds to the total distance covered by the COP during a recording period.
Measured: 10 minutes
Difference of area of COP displacement between groups and experimental conditions
Area of COP displacement represents the area covered by COP during a recording period.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 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
- NCT06863246
- Sponsor's protocol ID
- 2025-CHITS-006
- Acronym
- NEUROTIGUE P
- 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
- Influence of Cognitive Load on Postural Control in People With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06863246
- Acronym / sponsor ID
- NEUROTIGUE P / 2025-CHITS-006
- Keywords
- COPD, Postural control, Variability, Non-linear, Cognitive task, Static balance
- 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
- 7 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.
Postural control impairment is common in people with COPD (pwCOPD), which can increase the risk of falls and affect quality of life. However, the majority of existing studies examine this postural control in isolation, without taking into account the cognitive demands that occur during activities of daily living during which individuals are often required to perform a mental task while maintaining their balance. This research aims to fill this gap by studying how a cognitive task can influence postural control in pwCOPD. We hypothesized an impaired postural control in pwCOPD compared to healthy individuals, which would be exacerbated in presence of a cognitive task.
Detailed description
This observational study is based on the analyses of data (center of pressure displacement) recorded during the first visit of NEUROTIGUE study (NCT04028973).
Center of pressure (COP) displacement were recorded during 60s of static balance in four conditions (random order) :
- Eyes open without cognitive task
- Eyes open with cognitive task
- Eyes closed without cognitive task
- Eyes closed with cognitive task The cognitive task used was a working memory task : the 1-back task. COP displacement will be assess using a conjunction of parameters to provide a comprehensive understanding of postural control (e.g., amplitude, standard deviation, non-linear approaches).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | Other: Evaluation of cognitive task on static balance, Other: Evaluation of visual feedback on static balancePatients with chronic obstructive pulmonary disease |
| Control participants | – | Other: Evaluation of cognitive task on static balance, Other: Evaluation of visual feedback on static balanceHealthy 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)
- 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)
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 |
|---|---|---|
| Evaluation of cognitive task on static balanceStatic balance with and without cognitive task (i.e., 1-back task) | Other | Control participants, Patients with COPD |
| Evaluation of visual feedback on static balanceStatic balance with and without visual feedback (i.e., eyes closed and open). | Other | Control participants, Patients with COPD |
Primary outcome
Difference of the range of COP displacement between groups and experimental conditions
Time frame: 10 minutes
Range of COP displacement correspond to the maximal amplitude of the path of COP in anteroposterior and mediolateral directions.
3 secondary outcomes
Difference of Sample Entropy (SampEn) of COP displacement between groups and experimental conditions
Time frame: 10 minutes
Difference of total COP displacement between groups and experimental conditions
Time frame: 10 minutes
Difference of area of COP displacement between groups and experimental conditions
Time frame: 10 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 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 range of COP displacement between groups and experimental conditions (time frame: 10 minutes). 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; AzTrials last refreshed its copy on 30 Oct 2026.