NCT06863246

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 day

First QC Date

March 3, 2025

Last Update Submit

April 10, 2026

Conditions

Keywords

COPDPostural controlVariabilityNon-linearCognitive taskStatic balance

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Secondary Outcomes (3)

  • Difference of Sample Entropy (SampEn) of COP displacement between groups and experimental conditions

    10 minutes

  • Difference of total COP displacement between groups and experimental conditions

    10 minutes

  • Difference of area of COP displacement between groups and experimental conditions

    10 minutes

Other Outcomes (2)

  • Difference of mean COP position between groups and experimental conditions

    10 minutes

  • Difference of the mean speed of COP displacement between groups and experimental conditions

    10 minutes

Study Arms (2)

Patients with COPD

Patients with chronic obstructive pulmonary disease

Other: Evaluation of cognitive task on static balanceOther: Evaluation of visual feedback on static balance

Control participants

Healthy individuals

Other: Evaluation of cognitive task on static balanceOther: Evaluation of visual feedback on static balance

Interventions

Static balance with and without cognitive task (i.e., 1-back task)

Control participantsPatients with COPD

Static balance with and without visual feedback (i.e., eyes closed and open).

Control participantsPatients with COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants enrolled in NEUROTIGUE study (NCT04028973)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Toulon - Laboratoire J-AP2S

Toulon, VAR, 83100, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Marc Vallier, MD, PHD

    Université de Toulon

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 7, 2025

Study Start

March 7, 2025

Primary Completion

March 8, 2025

Study Completion

March 8, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations