Force Control in Chronic Obstructive Pulmonary Disease (NEUROTIGUE F)

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.

Study Overview

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

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • VAR
      • Toulon, VAR, France, 83000
        • Université de Toulon, laboratoires Laboratoire J-AP2S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants enrolled in NEUROTIGUE study (NCT04028973)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jean-Marc Vallier, MD, PHD, Université de Toulon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Actual)

March 8, 2025

Study Completion (Actual)

March 8, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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