- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03152344
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk. (Equil-BPCO)
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.
The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires:
- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.
Tests:
- Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
- Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
- 6 minute walk test evaluating endurance to submaximal exercise.
- Isokinetic maximal force of the quadriceps at 60°/s
- Balance control: posturography consisting in measuring variations when standing on a force platform.
- Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
- Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.
Analysis of the results:
We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.
Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).
Perspectives:
When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Auvergne
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Clermont-Ferrand, Auvergne, Francia, 63003
- CHU de Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- COPD confirmed by pulmonary function tests
- Long term oxygen therapy since at least 3 months in the LOT+ subgroup
Exclusion Criteria:
- Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
- Pulmonary rehabilitation in the last 3 months
- Any neurological disease affecting balance control.
- Inability to perform a walk test
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
COPD patients without chronic respiratory failure
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
|
COPD patients with home oxygen therapy
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of the Timed Up and Go test and the Berg Balance scale
Periodo de tiempo: at day 1
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Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
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at day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sensitivity of the TUG test and the BBS
Periodo de tiempo: at day 1
|
to detect fall as assessed by the Elderly Falls Screening Test.
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at day 1
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Difference in BBS score
Periodo de tiempo: at day 1
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between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).
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at day 1
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Identify predictive factors of fall risk
Periodo de tiempo: at day 1
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walk distance, quadriceps force, muscle mass, balance control.
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at day 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CHU-332
- 2016-A01188-43 (Otro identificador: 2016-A01188-43)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre COPD Diagnosed
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PharmaxisTerminado
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Liita Care ApSSuspendidoEPOC | Bronquitis copdDinamarca
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Gala Therapeutics, Inc.Activo, no reclutandoBronquitis crónica | Bronquitis copdEstados Unidos
Ensayos clínicos sobre Timed Up and Go
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Dalarna UniversityUppsala University; The Swedish Research CouncilReclutamientoDemencia | Defecto cognitivo leve | Demencia Mixta | Demencia de tipo Alzheimer | Deterioro Cognitivo Subjetivo | Demencia senilSuecia
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Acibadem UniversityMarmara UniversityTerminadoObesidad | Artritis de rodilla | Complicaciones de la artroplastia | Balance; DistorsionadoPavo
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University of Rhode IslandStuart Sinoff, MD; Peter J Snyder, MD; BayCare Health SystemReclutamientoCambio cognitivo | Enfermedad de Alzheimer | Envejecimiento | Defecto cognitivo leve | Demencia leveEstados Unidos
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Istanbul Medeniyet UniversityDesconocidoOsteoporosis Posmenopáusica | Balance; DistorsionadoPavo
-
Istanbul Medeniyet UniversityDesconocidoSarcopenia | Osteoporosis Posmenopáusica | Balance; DistorsionadoPavo
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University of FloridaReclutamientoFractura de fémur distalEstados Unidos
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Assiut UniversityDesconocidoEnfermedad pulmonar intersticial | Disfunción del músculo esquelético
-
Gazi UniversityTerminadoEsclerosis múltiplePavo
-
Istinye UniversityInscripción por invitaciónCarrera | Tele-evaluación | La prueba Timed Up & Go | Prueba de soporte de silla de 30 segundosPavo
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Gazi UniversityTerminadoEsclerosis Múltiple Recurrente-RemitentePavo