Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Life After STroke - the LAST Study (LAST)

9 de abril de 2020 actualizado por: Norwegian University of Science and Technology

Life After STroke - the LAST Study. A Norwegian Multi Centre Randomized Controlled Trial

The LAST study is a Norwegian multi site randomised controlled trial that intends to assess the effect of a long term follow up program after stroke. The program consists of a coordinating physiotherapist who will encourage and motivate included patients to perform at least 60 minutes of intensive motor training every week and 30 minutes of physical activity every day for 18 months after inclusion. The primary hypothesis is that patients receiving a long term follow up program after stroke will have better motor function at end of follow up than patients receiving standard care. A total of 390 home dwelling stroke patients living in the municipality of Trondheim, Asker and Bærum will be included at the out-patient clinic at St. Olavs Hospital or Bærum Hospital three months after their stroke. Included patients will be randomised to an intervention group receiving the long term follow up program or to a control group receiving standard care. Motor function, mental health and physical functioning in daily life will be assessed at inclusion and 18 months later. The LAST study is funded by the Norwegian Research Council, the Norwegian University of Science and Technology and the Central Norway Regional Health Authority and will conclude at the end of 2015.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Supplement to the Life After Stroke - the LAST study ClinicalTrials.gov ID: NCT01467206

Changes in the planned statistical analysis, November 9, 2015 The original plan for statistical analysis was published in; Askim T, Langhammer B, Ihle-Hansen H, Magnussen J, Engstad T, Indredavik B. A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke-The LAST Study. Stroke Res Treat. 2012;2012:392101. doi: 10.1155/2012/392101. Epub 2012 Nov 22.

Original plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Mann-Whitney U test will be used for secondary data not being normal distributed. In all analyses we will control for potential confounding factors, investigate effect modifications, and present both unadjusted and adjusted effects with 95% confidence intervals.

Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site) to explore trends within subgroups of patients.

Revised plan for statistical analysis Reporting will follow the CONSORT statement for parallel group randomized trials [40]. Descriptive statistics will be performed in order to present the population and the characteristic of the two groups. All analyses will be analysed as intention-to-treat analysis according to the CONSORT instructions. Analysis of covariance (ANCOVA) will be used to study differences between groups according to the primary endpoint, motor assessment scale at 18 months after inclusion. The ANCOVA model will include stroke severity, age, pre stroke disability, treatment group, and motor function at baseline as covariates. Similar ANCOVA analyses will be used for the relevant secondary endpoints. Mann-Whitney U test will be used for secondary data not being normal distributed.

Subanalysis will be performed according to the stratification variables (stroke severity, age above 80 and recruitment site), gender, and cognitive status (Mini Mental State below 25), to explore trends within subgroups of patients.

Missing values will be handled using single imputation (typically for items on instrument scales), or by multiple imputation, as appropriate.

Tipo de estudio

Intervencionista

Inscripción (Actual)

380

Fase

  • No aplica

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.

Ubicaciones de estudio

  • Noruega
      • Sandvika, Noruega
        • Bærum Hospital
      • Trondheim, Noruega
        • St. Olavs Hospital

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

18 años a 95 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of stroke according to WHO's definition of stroke
  • Living in the city of Trondheim or the municipalities of Asker or Bærum
  • Included 2.5 - 4 months after stroke
  • Modified Rankin Scale 0 - 4
  • Living at home
  • Mini Mental State Examination > 20 or > 16 if aphasia
  • Provide informed consent

Exclusion Criteria:

  • Are already included in the study
  • Are included in other experimental studies
  • Unstable coronary function
  • Uncompensated heartfailure
  • Other diseases that make it difficult to complete the intervention

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Atención estándar
Conductual: Standard care
Standard care as it is given to all stoke patients after stroke
Experimental: Long term follow up program
Conductual: Long term follow up by a coordinating physiotherapist
Monthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor Assessment Scale
Periodo de tiempo: 18 months after inclusion
A measure of over all motor function
18 months after inclusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Barthel Index
Periodo de tiempo: 18 months follow up
A measure of activities of daily living
18 months follow up
Modified Rankin Scale
Periodo de tiempo: 18 months follow up
A measure of dependency/independency
18 months follow up
Berg Balance Scale
Periodo de tiempo: 18 months follow up
A measure of balance related to basic movement tasks
18 months follow up
Timed Up and Go
Periodo de tiempo: 18 months follow up
A measure of balance related to transfer and walking
18 months follow up
Sit to stand test
Periodo de tiempo: 18 months follow up
A measure of dynamic muscle strength according to a sit to stand task
18 months follow up
Six minute walk test
Periodo de tiempo: 18 months follow up
A measure of endurance
18 months follow up
Stroke Impact Scale
Periodo de tiempo: 18 months follow up
A measure of health related quality of life after stroke
18 months follow up
EuroQol 5D
Periodo de tiempo: 18 months follow up
A simple measure of health related quality of life for the general population
18 months follow up
Fatigue Severity Scale
Periodo de tiempo: 18 months follow up
A measure of the presence of fatigue
18 months follow up
One simple question on fatigue from the HUNT3 questionnaire
Periodo de tiempo: 18 months follow up
A simple question used to assess tiredness in teh general Norwegian population
18 months follow up
Hospital Anxiety and Depression Scale
Periodo de tiempo: 18 months follow up
A measure of anxiety and depression
18 months follow up
Mini Mental State Examination
Periodo de tiempo: 18 months follow up
A measure of cognitive function
18 months follow up
Montreal Cognitive Assessment
Periodo de tiempo: 18 months follow up
A measure of cognitive function related to vascular dementia
18 months follow up
falls
Periodo de tiempo: 6, 12 and 18 months
Serious falls will be recorded from the patients hospital records
6, 12 and 18 months
Readmission to hospital
Periodo de tiempo: 6, 12 and 18 months
Number of readmissions to hospital will be recorded from the patients medical records
6, 12 and 18 months
Death
Periodo de tiempo: 6, 12 and 18 months
Information about death will be collected from the Norwegain Death Registry
6, 12 and 18 months
Fractures
Periodo de tiempo: 6, 12 and 18 months
Information about fractures during follow up will be collected from the patients medical records
6, 12 and 18 months
Cardiovascular events
Periodo de tiempo: 6, 12 and 18 months
Information about any cardiovascular events will be collected from the patients medical record
6, 12 and 18 months
Cerebrovascular events
Periodo de tiempo: 6, 12 and 18 months
Information about any cerebrovascular events during follow up will be collected from teh patient's medical records
6, 12 and 18 months
International Physical Activity Questionnaire
Periodo de tiempo: 6, 12 and 18 months
A measure of physical activity over the last week
6, 12 and 18 months
Physical activity assessed by ActivPAL sensor system
Periodo de tiempo: 6, 12 and 18 months
A sensor system to assess the amount of physical activity during a 4-7 day period
6, 12 and 18 months
Three simple questions on physical activity from the HUNT questionnaire
Periodo de tiempo: 18 months
A simple measure of physical activity
18 months
Health costs
Periodo de tiempo: 6, 12 and 18 months
Information about the use of health services will be collected by reviewing the patients' hospital records and records in primary health care system.
6, 12 and 18 months
National Institutes of Health Stroke Scale
Periodo de tiempo: 18 months follow up
A measure of stroke severity
18 months follow up
Modified Ashworth Scale
Periodo de tiempo: 18 months follow up
A measure to rate the degree of spasticity after stroke
18 months follow up
Gait speed
Periodo de tiempo: 18 months follow up
A simple measure of maximum gait speed across a 10 metres distance
18 months follow up
Trailmaking test A and B
Periodo de tiempo: 18 months follow up
A simple measure of executive cognitive function
18 months follow up
DS-14
Periodo de tiempo: 18 months follow up
A standard assessment of negative affectivity, social inhibition, and type D personality, which might be related to poor cardiovascular prognosis.
18 months follow up

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
VO2-peak
Periodo de tiempo: 18 months follow up

VO2-peak is obtained by use of a symptom limited treadmill test to measure cardiovascular fitness.

This measure is only used in the Trondheim arm of the study
18 months follow up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Norwegian University of Science and Technology

Colaboradores

The Research Council of Norway
Asker & Baerum Hospital
St. Olavs Hospital
Helse Midt-Norge

Investigadores

  • Director de estudio: Bent Indredavik, Prof, National Taiwan Normal University
  • Investigador principal: Torunn Askim, PhD, National Taiwan Normal University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Actual)

1 de noviembre de 2011

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

31 de octubre de 2011

Primero enviado que cumplió con los criterios de control de calidad

4 de noviembre de 2011

Publicado por primera vez (Estimar)

8 de noviembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de abril de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

9 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 205309/H10

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

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 Infarto cerebral

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Estonia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir