Clinical trial NCT05211674: Analysis of Postural Control of COPD Patients (ATTRACTION)
Official title: Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
postural balance
activities of daily living
Lead sponsor: University of Rennes 2
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
First posted: 2022-01-27
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients that realize their medical follow-up at University Hospital of Rennes

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.


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:

1. the presence of long-term or exercise-based oxygen therapy,
2. the presence of a medically diagnosed pathology causing manifest disorders of balance,
3. the inability to walk 150 m without stopping and to climb or descend stairs,
4. a history of pneumonectomy or lobectomy within the last six months,
5. the existence of an acute respiratory exacerbation within the last two months,
6. the presence of obvious cognitive impairment that impairs comprehension of instructions,
7. body mass index less than 21 or more than 35 kg/m².
8. 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
   * Person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research
   * Minor
   * Person subject to a period of exclusion for other research
   * Person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure
9. Person under psychiatric care

Primary outcomes:
measure: Margins of stability
timeFrame: Clinical assessment at baseline
measure: Margins of stability variability
timeFrame: Clinical assessment at baseline
measure: Center of Mass velocity
timeFrame: Clinical assessment at baseline
measure: Center of mass displacement
timeFrame: Clinical assessment at baseline
Secondary outcomes:
measure: Evolution of articular angulations
timeFrame: Clinical assessment at baseline
measure: Centre of pressure (CoP) Area
timeFrame: Clinical assessment at baseline
measure: Centre of pressure (CoP) velocity
timeFrame: Clinical assessment at baseline
measure: Centre of pressure (CoP) variability
timeFrame: Clinical assessment at baseline
measure: Gait Cadence
timeFrame: Clinical assessment at baseline
measure: Gait velocity
timeFrame: Clinical assessment at baseline
measure: Gait phases duration
timeFrame: Clinical assessment at baseline
measure: Step width
timeFrame: Clinical assessment at baseline
measure: Step length
timeFrame: Clinical assessment at baseline
measure: Completion time of the Modified Glittre ADL
timeFrame: Clinical assessment at baseline
measure: Completion time of the timed up and go test
timeFrame: Clinical assessment at baseline
Other outcomes:
measure: Dyspnea assessment scale
timeFrame: Clinical assessment at baseline
measure: Heart rate
timeFrame: Clinical assessment at baseline
measure: Leg discomfort scale
timeFrame: Clinical assessment at baseline
measure: Visual analog scale for pain
timeFrame: Clinical assessment at baseline
measure: Pain Drawing scale
timeFrame: Clinical assessment at baseline
measure: Multi-dimensional dyspnea profile (MDP)
timeFrame: Clinical assessment at baseline
measure: London chest activity of daily living questionnaire (LCADL)
timeFrame: Clinical assessment at baseline
measure: Modified Medical Research Council Scale (MMRC)
timeFrame: Clinical assessment at baseline
measure: Charlson Index
timeFrame: Clinical assessment at baseline
measure: Body composition
timeFrame: Clinical assessment at baseline
measure: Maximal inspiratory pressure
timeFrame: Clinical assessment at baseline
measure: Falls Efficacy Scale - International
timeFrame: Clinical assessment at baseline
measure: Number of anterior falls
timeFrame: Clinical assessment at baseline
measure: General Practioner assessment of Cognition (GP-COG)
timeFrame: Clinical assessment at baseline
measure: International Physical Activity Questionnaire (IPAQ short-form)
timeFrame: Clinical assessment at baseline
measure: COPD assessment test (CAT)
timeFrame: Clinical assessment at baseline
Locations:
Study officials:
affiliation: University Hospital of Rennes
name: Graziella Brinchault, MD
role: PRINCIPAL_INVESTIGATOR
References: