Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: quantified analysis of postural control during activities of daily living

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: Romain Pichon, MSc; Phone Number: 0667774267; Email: r.pichon@ifpek.org
• Study Contact Backup: Name: Armel Cretual, PhD; Email: armel.cretual@univ-rennes2.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Other: 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)
COPD patients	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of articular angulations	Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests	Clinical assessment at baseline
Centre of pressure (CoP) Area	Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test	Clinical assessment at baseline
Centre of pressure (CoP) velocity	Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test	Clinical assessment at baseline
Centre of pressure (CoP) variability	Coefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test	Clinical assessment at baseline
Gait Cadence	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Gait velocity	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Gait phases duration	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Step width	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Step length	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Completion time of the Modified Glittre ADL	Time to complete the modified Glittre-ADL test	Clinical assessment at baseline
Completion time of the timed up and go test	Time to complete the timed up and go test test	Clinical assessment at baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea assessment scale	assessed by the modified Borg Scale which is a 0 to 10 scale (0 representing no dyspnea, 10 representing the worst imaginable dyspnea). Dyspnea is assessed before, during and after the functional tests	Clinical assessment at baseline
Heart rate	assessed before, during and after functional tests	Clinical assessment at baseline
Leg discomfort scale	assessed on a 0 to 10 scale (0 representing no discomfort, 10 representing the worst imaginable discomfort).Leg discomfort is assessed before, during and after the functional tests	Clinical assessment at baseline
Visual analog scale for pain	Pain is assessed by a visual analog scale which is a 100mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling (Here no pain and the worst imaginable pain)	Clinical assessment at baseline
Pain Drawing scale	participants are invited to identify on a body chart the location of experienced pain.	Clinical assessment at baseline
Multi-dimensional dyspnea profile (MDP)	Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea	Clinical assessment at baseline
London chest activity of daily living questionnaire (LCADL)	Dyspnea assessment tool which investigates the impact of dyspnea on 15 activities of daily living. A score from 0 to 5 is given for each activity, 5 representing an higher impact of dyspnea on the activity.	Clinical assessment at baseline
Modified Medical Research Council Scale (MMRC)	Dyspnea assessment tool which investigates impact of dyspnea in participants life. This is a 0 to 4 scale with descriptors associated to each number. 4 representing the most severe impact of dyspnea.	Clinical assessment at baseline
Charlson Index	Comorbidities assessment tool which list 19 potential comorbidities associated with a weighted score. The points are attributed when the comorbidity is present. A total score is then calculated. An higher score indicates an higher severity.	Clinical assessment at baseline
Body composition	Determination of fat free mass and fat mass by bioelectrical impedance analysis.	Clinical assessment at baseline
Maximal inspiratory pressure	inspiratory muscles strength assessment	Clinical assessment at baseline
Falls Efficacy Scale - International	Fear of falling assessment tool which investigates fear of falling in 16 different activities. Each activity is scored from 0 to 4 (4 representing an higher fear of falling in this activity). The total score range from 16 to 64 (an higher score indicating a most severe fear of falling)	Clinical assessment at baseline
Number of anterior falls	assessment of fall occurence in the last 12 months	Clinical assessment at baseline
General Practioner assessment of Cognition (GP-COG)	assessment of cognitive function. GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)	Clinical assessment at baseline
International Physical Activity Questionnaire (IPAQ short-form)	assessment of daily physical activity and sedentarity	Clinical assessment at baseline
COPD assessment test (CAT)	quality of life assessment tool	Clinical assessment at baseline

Collaborators and Investigators

• Sponsor: University of Rennes 2
• Collaborators: Rennes University Hospital
• Investigators: Principal Investigator: Graziella Brinchault, MD, University Hospital of Rennes

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: activities of daily living; postural balance; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: M2S-ATTRACTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No