Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)
14 de enero de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Anticipado)
32
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Romain Pichon, MSc
- Número de teléfono: 0667774267
- Correo electrónico: r.pichon@ifpek.org
Copia de seguridad de contactos de estudio
- Nombre: Armel Cretual, PhD
- Correo electrónico: armel.cretual@univ-rennes2.fr
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
COPD patients that realize their medical follow-up at University Hospital of Rennes
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Controles saludables
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
|
Pacientes con EPOC
|
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Margins of stability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
|
Center of mass displacement
Periodo de tiempo: Clinical assessment at baseline
|
Parameter of participant's Centre of Mass (CoM) during the functional tests
|
Clinical assessment at baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evolution of articular angulations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Clinical assessment at baseline
|
Time to complete the timed up and go test test
|
Clinical assessment at baseline
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dyspnea assessment scale
Periodo de tiempo: 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
Periodo de tiempo: Clinical assessment at baseline
|
assessed before, during and after functional tests
|
Clinical assessment at baseline
|
|
Leg discomfort scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Clinical assessment at baseline
|
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
|
Clinical assessment at baseline
|
|
Maximal inspiratory pressure
Periodo de tiempo: Clinical assessment at baseline
|
inspiratory muscles strength assessment
|
Clinical assessment at baseline
|
|
Falls Efficacy Scale - International
Periodo de tiempo: 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
Periodo de tiempo: Clinical assessment at baseline
|
assessment of fall occurence in the last 12 months
|
Clinical assessment at baseline
|
|
General Practioner assessment of Cognition (GP-COG)
Periodo de tiempo: 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)
Periodo de tiempo: Clinical assessment at baseline
|
assessment of daily physical activity and sedentarity
|
Clinical assessment at baseline
|
|
COPD assessment test (CAT)
Periodo de tiempo: Clinical assessment at baseline
|
quality of life assessment tool
|
Clinical assessment at baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Graziella Brinchault, MD, University Hospital of Rennes
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de febrero de 2022
Finalización primaria (Anticipado)
1 de septiembre de 2022
Finalización del estudio (Anticipado)
1 de abril de 2023
Fechas de registro del estudio
Enviado por primera vez
23 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
14 de enero de 2022
Publicado por primera vez (Actual)
27 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
14 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M2S-ATTRACTION
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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