Analysis of Postural Control of COPD Patients (ATTRACTION)

Chronic Obstructive Pulmonary Disease Clinical Trial

— ATTRACTION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05211674
• Other study ID #: M2S-ATTRACTION
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: April 2023

Study information

• Verified date: January 2022
• Source: University of Rennes 2
• Contact: Romain Pichon, MSc
• Phone: 0667774267
• Email: r.pichon[@]ifpek.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Rennes 2	Rennes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Heart rate	assessed before, during and after functional tests	Clinical assessment at baseline
Other	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
Other	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
Other	Pain Drawing scale	participants are invited to identify on a body chart the location of experienced pain.	Clinical assessment at baseline
Other	Multi-dimensional dyspnea profile (MDP)	Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea	Clinical assessment at baseline
Other	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
Other	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
Other	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
Other	Body composition	Determination of fat free mass and fat mass by bioelectrical impedance analysis.	Clinical assessment at baseline
Other	Maximal inspiratory pressure	inspiratory muscles strength assessment	Clinical assessment at baseline
Other	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
Other	Number of anterior falls	assessment of fall occurence in the last 12 months	Clinical assessment at baseline
Other	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
Other	International Physical Activity Questionnaire (IPAQ short-form)	assessment of daily physical activity and sedentarity	Clinical assessment at baseline
Other	COPD assessment test (CAT)	quality of life assessment tool	Clinical assessment at baseline
Primary	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
Primary	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
Primary	Center of Mass velocity	Parameter of participant's Centre of Mass (CoM) during the functional tests	Clinical assessment at baseline
Primary	Center of mass displacement	Parameter of participant's Centre of Mass (CoM) during the functional tests	Clinical assessment at baseline
Secondary	Evolution of articular angulations	Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests	Clinical assessment at baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Gait Cadence	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Secondary	Gait velocity	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Secondary	Gait phases duration	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Secondary	Step width	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Secondary	Step length	spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test	Clinical assessment at baseline
Secondary	Completion time of the Modified Glittre ADL	Time to complete the modified Glittre-ADL test	Clinical assessment at baseline
Secondary	Completion time of the timed up and go test	Time to complete the timed up and go test test	Clinical assessment at baseline