Skip to main content
Clinical Trials/NCT05211674
NCT05211674
Unknown
Not Applicable

Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living

University of Rennes 20 sites32 target enrollmentFebruary 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University of Rennes 2
Enrollment
32
Primary Endpoint
Margins of stability variability
Last Updated
4 years ago

Overview

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects. This alteration is associated with a greater functional limitation and a higher risk of falling. Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) Several clinical factors are associated with these changes.

Registry
clinicaltrials.gov
Start Date
February 2022
End Date
April 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Rennes 2
Responsible Party
Principal Investigator
Principal Investigator

Graziella Brinchault

Principal investigator

Rennes University Hospital

Eligibility Criteria

Inclusion Criteria

  • COPD patients GOLD stage 2 and 3 (A-D)
  • In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.

Exclusion Criteria

  • the presence of long-term or exercise-based oxygen therapy,
  • the presence of a medically diagnosed pathology causing manifest disorders of balance,
  • the inability to walk 150 m without stopping and to climb or descend stairs,
  • a history of pneumonectomy or lobectomy within the last six months,
  • the existence of an acute respiratory exacerbation within the last two months,
  • the presence of obvious cognitive impairment that impairs comprehension of instructions,
  • body mass index less than 21 or more than 35 kg/m².
  • Person referred to in articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the public health code:
  • Pregnant woman, woman in labour or nursing mother
  • Person deprived of liberty by judicial or administrative decision

Outcomes

Primary Outcomes

Margins of stability variability

Time Frame: Clinical assessment at baseline

Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests

Margins of stability

Time Frame: Clinical assessment at baseline

Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests

Center of Mass velocity

Time Frame: Clinical assessment at baseline

Parameter of participant's Centre of Mass (CoM) during the functional tests

Center of mass displacement

Time Frame: Clinical assessment at baseline

Parameter of participant's Centre of Mass (CoM) during the functional tests

Secondary Outcomes

  • Centre of pressure (CoP) Area(Clinical assessment at baseline)
  • Centre of pressure (CoP) velocity(Clinical assessment at baseline)
  • Step length(Clinical assessment at baseline)
  • Completion time of the timed up and go test(Clinical assessment at baseline)
  • Evolution of articular angulations(Clinical assessment at baseline)
  • Gait velocity(Clinical assessment at baseline)
  • Gait phases duration(Clinical assessment at baseline)
  • Step width(Clinical assessment at baseline)
  • Centre of pressure (CoP) variability(Clinical assessment at baseline)
  • Gait Cadence(Clinical assessment at baseline)
  • Completion time of the Modified Glittre ADL(Clinical assessment at baseline)

Similar Trials