Analysis of Postural Control of COPD Patients (ATTRACTION)

NCT05211674 | Unknown

• 1 other identifier: M2S-ATTRACTION
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

chronic obstructive pulmonary disease; postural balance; activities of daily living

Outcome Measures

Primary Outcomes (4)

• Margins of stability

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

  Clinical assessment at baseline

• Margins of stability variability

  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

  Clinical assessment at baseline

• Center of Mass velocity

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

  Clinical assessment at baseline

• Center of mass displacement

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

  Clinical assessment at baseline

Secondary Outcomes (11)

• Evolution of articular angulations

  Clinical assessment at baseline

• Centre of pressure (CoP) Area

  Clinical assessment at baseline

• Centre of pressure (CoP) velocity

  Clinical assessment at baseline

• Centre of pressure (CoP) variability

  Clinical assessment at baseline

• Gait Cadence

  Clinical assessment at baseline

Other Outcomes (16)

• Dyspnea assessment scale

  Clinical assessment at baseline

• Heart rate

  Clinical assessment at baseline

• Leg discomfort scale

  Clinical assessment at baseline

Study Arms (2)

COPD patients

Other: quantified analysis of postural control during activities of daily living

Healthy controls

Other: quantified analysis of postural control during activities of daily living

Interventions

quantified analysis of postural control during activities of daily living OTHER

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

COPD patients; Healthy controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients that realize their medical follow-up at University Hospital of Rennes

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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 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
• Person under psychiatric care

Sponsors & Collaborators

• University of Rennes 2: lead
• Rennes University Hospital: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Graziella Brinchault, MD

  University Hospital of Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain Pichon, MSc

CONTACT

0667774267; r.pichon@ifpek.org

Armel Cretual, PhD

CONTACT

armel.cretual@univ-rennes2.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 27, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: April 1, 2023
• Last Updated: January 27, 2022

Record last verified: 2022-01