Aerobic Exercise in Early Subacute Stroke
Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ability to understand Swedish language.
- Ability to walk 5 meters with or without the support of any means or person.
- Be able to get up on a cycle ergometer and cycle in their own chosen pace.
- Approval of medically responsible physician to conduct physical training in groups.
Exclusion Criteria:
- Medical or neurological diseases that may affect the exercise execution.
- Patients for whom transportation to and from hospital can not be arranged during intervention period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exercise recommendation
Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts
|
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate. |
|
Experimental: Aerobic exercise
The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added. The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20, Rate of Perceived Exertion (Borg 's RPE scale) Two fitness goals was to be achieved during the training session: 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) .Which corresponds to 85% of maximum heart rate. |
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aerobic capacity
Periodo de tiempo: Baseline,3month
|
cardiorespiratory stress test (Watt)
|
Baseline,3month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Balance
Periodo de tiempo: Baseline,3month
|
Time Up and Go(TUG) ,Single Leg Stance(SLS)
|
Baseline,3month
|
|
Walking capacity
Periodo de tiempo: Baseline,3month
|
Six minute walk test (6MWT ), 10 meters Walking test
|
Baseline,3month
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EQ5-D
Periodo de tiempo: Baseline,3month,6month
|
Quality of life
|
Baseline,3month,6month
|
|
Stroke Impact Scale
Periodo de tiempo: Baseline,3month,6month
|
Recovery after stroke, participation
|
Baseline,3month,6month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Klas Sandberg, Msc,RPT, Rehab East, Local Health Care Östergötland County Council
- Investigador principal: Marie Kleist, Bsc,RPT, Rehab East, Local Health Care Östergötland County Council
- Investigador principal: Lars Falk, PhD,MD, Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
- Investigador principal: Paul Enthoven, PhD,RPT, Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University
Publicaciones y enlaces útiles
Publicaciones Generales
- Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.
- Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2010/396-31
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. .