Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)
14. januar 2022 oppdatert av: Graziella Brinchault, University of Rennes 2
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Forventet)
32
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Romain Pichon, MSc
- Telefonnummer: 0667774267
- E-post: r.pichon@ifpek.org
Studer Kontakt Backup
- Navn: Armel Cretual, PhD
- E-post: armel.cretual@univ-rennes2.fr
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
COPD patients that realize their medical follow-up at University Hospital of Rennes
Beskrivelse
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:
- 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 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
- Person under psychiatric care
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Sunne kontroller
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
|
KOLS-pasienter
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Margins of stability
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
|
Center of mass displacement
Tidsramme: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of articular angulations
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Gait velocity
Tidsramme: Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Gait phases duration
Tidsramme: Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Step width
Tidsramme: Clinical assessment at baseline
|
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
|
Clinical assessment at baseline
|
|
Step length
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
Time to complete the modified Glittre-ADL test
|
Clinical assessment at baseline
|
|
Completion time of the timed up and go test
Tidsramme: Clinical assessment at baseline
|
Time to complete the timed up and go test test
|
Clinical assessment at baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dyspnea assessment scale
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
assessed before, during and after functional tests
|
Clinical assessment at baseline
|
|
Leg discomfort scale
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
participants are invited to identify on a body chart the location of experienced pain.
|
Clinical assessment at baseline
|
|
Multi-dimensional dyspnea profile (MDP)
Tidsramme: Clinical assessment at baseline
|
Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
|
Clinical assessment at baseline
|
|
London chest activity of daily living questionnaire (LCADL)
Tidsramme: Clinical assessment at baseline
|
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)
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
|
Clinical assessment at baseline
|
|
Maximal inspiratory pressure
Tidsramme: Clinical assessment at baseline
|
inspiratory muscles strength assessment
|
Clinical assessment at baseline
|
|
Falls Efficacy Scale - International
Tidsramme: Clinical assessment at baseline
|
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
Tidsramme: Clinical assessment at baseline
|
assessment of fall occurence in the last 12 months
|
Clinical assessment at baseline
|
|
General Practioner assessment of Cognition (GP-COG)
Tidsramme: Clinical assessment at baseline
|
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)
Tidsramme: Clinical assessment at baseline
|
assessment of daily physical activity and sedentarity
|
Clinical assessment at baseline
|
|
COPD assessment test (CAT)
Tidsramme: Clinical assessment at baseline
|
quality of life assessment tool
|
Clinical assessment at baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Graziella Brinchault, MD, University Hospital of Rennes
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. februar 2022
Primær fullføring (Forventet)
1. september 2022
Studiet fullført (Forventet)
1. april 2023
Datoer for studieregistrering
Først innsendt
23. november 2021
Først innsendt som oppfylte QC-kriteriene
14. januar 2022
Først lagt ut (Faktiske)
27. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M2S-ATTRACTION
Plan for individuelle deltakerdata (IPD)
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