Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)
14 janvier 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Anticipé)
32
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Romain Pichon, MSc
- Numéro de téléphone: 0667774267
- E-mail: r.pichon@ifpek.org
Sauvegarde des contacts de l'étude
- Nom: Armel Cretual, PhD
- E-mail: armel.cretual@univ-rennes2.fr
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
COPD patients that realize their medical follow-up at University Hospital of Rennes
La 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:
- 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Contrôles sains
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
|
Patients atteints de MPOC
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Margins of stability
Délai: 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
Délai: 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
Délai: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
|
Center of mass displacement
Délai: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evolution of articular angulations
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Clinical assessment at baseline
|
Time to complete the timed up and go test test
|
Clinical assessment at baseline
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dyspnea assessment scale
Délai: 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
Délai: Clinical assessment at baseline
|
assessed before, during and after functional tests
|
Clinical assessment at baseline
|
|
Leg discomfort scale
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: Clinical assessment at baseline
|
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
|
Clinical assessment at baseline
|
|
Maximal inspiratory pressure
Délai: Clinical assessment at baseline
|
inspiratory muscles strength assessment
|
Clinical assessment at baseline
|
|
Falls Efficacy Scale - International
Délai: 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
Délai: Clinical assessment at baseline
|
assessment of fall occurence in the last 12 months
|
Clinical assessment at baseline
|
|
General Practioner assessment of Cognition (GP-COG)
Délai: 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)
Délai: Clinical assessment at baseline
|
assessment of daily physical activity and sedentarity
|
Clinical assessment at baseline
|
|
COPD assessment test (CAT)
Délai: Clinical assessment at baseline
|
quality of life assessment tool
|
Clinical assessment at baseline
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Graziella Brinchault, MD, University Hospital of Rennes
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 février 2022
Achèvement primaire (Anticipé)
1 septembre 2022
Achèvement de l'étude (Anticipé)
1 avril 2023
Dates d'inscription aux études
Première soumission
23 novembre 2021
Première soumission répondant aux critères de contrôle qualité
14 janvier 2022
Première publication (Réel)
27 janvier 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 janvier 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 janvier 2022
Dernière vérification
1 janvier 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M2S-ATTRACTION
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .