- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06871670
Force Control in Chronic Obstructive Pulmonary Disease (NEUROTIGUE F)
Knee Extensors Force Control in People With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
VAR
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Toulon, VAR, France, 83000
- Université de Toulon, laboratoires Laboratoire J-AP2S
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
For all participants :
-Subject who has not objected to the reuse of data collected
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with COPD
Patients with chronic obstructive pulmonary disease
|
Brief isometric contractions performed at 10, 20, 30, 40, 50 and 60% of maximal voluntary force in a random order.
|
|
Control participants
Healthy individuals
|
Brief isometric contractions performed at 10, 20, 30, 40, 50 and 60% of maximal voluntary force in a random order.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10-min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
RMSE (%) is calculated as the absolute difference between the average produced force and the target force expressed as a percentage of the target.
|
10-min
|
|
Difference of Sample Entropy (SampEn) of force signal between COPD patients and healthy participants for different contraction intensities.
Time Frame: 10-min
|
SampEn is a non-linear approach allowing to quantify the regularity of force signal.
|
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
|
DET from RQA represent another non-linear approach allowing to assess the regularity of force signal.
|
10-min
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jean-Marc Vallier, MD, PHD, Université de Toulon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-CHITS-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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