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Analysis of Postural Control of COPD Patients (ATTRACTION)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05211674
Acronym
ATTRACTION
Enrollment
32
Registered
2022-01-27
Start date
2022-02-28
Completion date
2023-04-30
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

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.

Interventions

OTHERquantified 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)

Sponsors

Rennes University Hospital
CollaboratorOTHER
University of Rennes 2
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Margins of stabilityClinical assessment at baselinePostural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Margins of stability variabilityClinical assessment at baselineCoefficient 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
Center of Mass velocityClinical assessment at baselineParameter of participant's Centre of Mass (CoM) during the functional tests
Center of mass displacementClinical assessment at baselineParameter of participant's Centre of Mass (CoM) during the functional tests

Secondary

MeasureTime frameDescription
Gait CadenceClinical assessment at baselinespatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Gait velocityClinical assessment at baselinespatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Gait phases durationClinical assessment at baselinespatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Evolution of articular angulationsClinical assessment at baselineArticular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
Step lengthClinical assessment at baselinespatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Completion time of the Modified Glittre ADLClinical assessment at baselineTime to complete the modified Glittre-ADL test
Completion time of the timed up and go testClinical assessment at baselineTime to complete the timed up and go test test
Step widthClinical assessment at baselinespatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Centre of pressure (CoP) AreaClinical assessment at baselineParameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Centre of pressure (CoP) velocityClinical assessment at baselineParameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Centre of pressure (CoP) variabilityClinical assessment at baselineCoefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test

Other

MeasureTime frameDescription
Dyspnea assessment scaleClinical assessment at baselineassessed 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
COPD assessment test (CAT)Clinical assessment at baselinequality of life assessment tool
Heart rateClinical assessment at baselineassessed before, during and after functional tests
Leg discomfort scaleClinical assessment at baselineassessed 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
Visual analog scale for painClinical assessment at baselinePain 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)
Pain Drawing scaleClinical assessment at baselineparticipants are invited to identify on a body chart the location of experienced pain.
Multi-dimensional dyspnea profile (MDP)Clinical assessment at baselineDyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
London chest activity of daily living questionnaire (LCADL)Clinical assessment at baselineDyspnea 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.
Modified Medical Research Council Scale (MMRC)Clinical assessment at baselineDyspnea 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.
Charlson IndexClinical assessment at baselineComorbidities 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.
Body compositionClinical assessment at baselineDetermination of fat free mass and fat mass by bioelectrical impedance analysis.
Maximal inspiratory pressureClinical assessment at baselineinspiratory muscles strength assessment
Falls Efficacy Scale - InternationalClinical assessment at baselineFear 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)
Number of anterior fallsClinical assessment at baselineassessment of fall occurence in the last 12 months
General Practioner assessment of Cognition (GP-COG)Clinical assessment at baselineassessment of cognitive function. GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)
International Physical Activity Questionnaire (IPAQ short-form)Clinical assessment at baselineassessment of daily physical activity and sedentarity

Contacts

Primary ContactRomain Pichon, MSc
r.pichon@ifpek.org0667774267
Backup ContactArmel Cretual, PhD
armel.cretual@univ-rennes2.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026