Analysis of Postural Control of COPD Patients (ATTRACTION)

NCT ID: NCT05211674

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

quantified analysis of postural control during activities of daily living

Intervention Type: OTHER

functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)

Healthy controls

quantified analysis of postural control during activities of daily living

Intervention Type: OTHER

functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)

Interventions

quantified analysis of postural control during activities of daily living

functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: collaborator

University of Rennes 2

OTHER

Sponsor Role: lead

Responsible Party

Graziella Brinchault

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graziella Brinchault, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rennes

Central Contacts

Romain Pichon, MSc

Role: CONTACT

r.pichon@ifpek.org

0667774267

Armel Cretual, PhD

Role: CONTACT

armel.cretual@univ-rennes2.fr

Other Identifiers

M2S-ATTRACTION

Identifier Type: -

Identifier Source: org_study_id