- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01067495
Adapted Cardiac Rehabilitation After Stroke
Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke.
The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking, risk factors, community integration and quality of life.
The investigators anticipate that cardiac rehabilitation may be appropriately adapted to accommodate individuals with stroke who have a range of functional abilities, and that this program is effective in improving aerobic capacity, walking ability and stroke risk factors. The investigators also anticipate participants will demonstrate improved community integration and quality of life following this program.
Descripción general del estudio
Descripción detallada
There are many parallels between heart disease in stroke, including their cardiovascular etiologies, presence of co-morbidities and similarities in risk factors. Cardiac rehabilitation is a well-established and successful model of care for individuals with heart disease that is focused on exercise and risk factor modification. Yet analogous secondary prevention programs for the stroke program are not readily available.
The main research question is: What is the feasibility and effect of cardiac rehabilitation in individuals following stroke?
The objectives are:
- To determine if stroke survivors are able and willing to participate in a cardiac rehabilitation program. Specifically, to determine the feasibility of the cardiac rehabilitation program in individuals following stroke as determined by compliance to attendance and training requirements.
To determine if a cardiac rehabilitation program will have a meaningful benefit, among chronic stroke survivors, on:
- walking capacity and ability: considering functional capacity [endurance / distance] and quality [neuromotor control],
- community integration: considering quantity [activity monitors] and quality [index of reintegration to normal living] of activity
- health-related quality of life: as determined by stroke specific index
- risk factors for subsequent stroke: including exercise capacity, blood pressure, blood lipid profile
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M4G 1R7
- Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Chedoke-McMaster Stroke Assessment (CMSA) Scale Leg Score between 3 and 7
- At least 3 months post-stroke
- Ability to understand the process and instructions for exercise training and provide informed consent
- Ability to complete 6-minute walk test
Exclusion Criteria:
- Resting blood pressure greater than 160/100 despite medication
- Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
- Unstable angina
- Orthostatic blood pressure decrease of > 20 mm Hg with symptoms
- Hypertrophic cardiomyopathy
- Other musculoskeletal impairments which would limit the participant's ability to cycle or walk
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Cognitive and/or behavioural issues that would limit participation in exercise testing and training
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ejercicio
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Participants will participate in a 6-month cardiac rehabilitation exercise program.
This program will include aerobic and resistance training, and education sessions on risk factor management.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
Periodo de tiempo: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
Periodo de tiempo: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Oh, MD, Toronto Rehabilitation Institute
- Investigador principal: William E McIlroy, PhD, University of Waterloo
Publicaciones y enlaces útiles
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
- HSFO-SRA5977
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. .
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