Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS)
3 de septiembre de 2026 actualizado por: University of Alberta
Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.
Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.
The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.
Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.
The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.
The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
150
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.
Estudio Contacto
- Nombre: Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 2T9
- Aún no reclutando
- Foothills Medical Center
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
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Investigador principal:
- Victor Ezeugwu, PhD
-
Calgary, Alberta, Canadá, T2E 6V7
- Aún no reclutando
- Carewest Dr Vernon Fanning Centre
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
-
Investigador principal:
- Victor Ezeugwu, PhD
-
Edmonton, Alberta, Canadá, T6G 2B7
- Reclutamiento
- University of Alberta Hospital
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
-
Investigador principal:
- Victor Ezeugwu, PhD
-
Edmonton, Alberta, Canadá, T5H 3V9
- Reclutamiento
- Royal Alexandra Hospital
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
-
Investigador principal:
- Victor Ezeugwu, PhD
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Edmonton, Alberta, Canadá, T6L 5X8
- Reclutamiento
- Grey Nuns Community Hospital
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
-
Investigador principal:
- Victor Ezeugwu, PhD
-
Edmonton, Alberta, Canadá, T5G 0B7
- Reclutamiento
- Glenrose Rehabilitation Hospital
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Contacto:
- Victor Ezeugwu, PhD
- Número de teléfono: 780 492 5108
- Correo electrónico: ezeugwu@ualberta.ca
-
Contacto:
- Charmaine van Eeden, PhD
- Número de teléfono: 780 248 2059
- Correo electrónico: vaneeden@ualberta.ca
-
Investigador principal:
- Victor Ezeugwu, PhD
-
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged 50 - or older
- Had an ischemic or hemorrhagic stroke within the last 3 months
- Have recently returned or are returning home from hospital
- Able to walk 5 meters with or without a gait aid
Exclusion Criteria:
- Previously diagnosed with a mobility limiting musculoskeletal condition
- Previously diagnosed with a mobility limiting neurological condition
- Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg)
- Are without access to an internet-enabled computer or mobile device
- Are enrolled in another interventional trial such as exercise or neuroprotection trials
- Have aphasia or are unable to provide consent in English.
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 cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Early BIG STEPS
Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.
Participants will start the BIG STEP intervention within 3 months of stroke onset.
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The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps.
Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment.
Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations.
|
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Otro: Delayed BIG STEPS
The waitlist control group will complete the BIG STEPS intervention after 6 months.
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The waitlist control group will complete the BIG STEPS intervention after 6 months.
During the waiting period they will receive usual care and educational materials.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical functioning: Step Counts
Periodo de tiempo: Difference in changes from baseline to 3 months (post intervention/post waiting)
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activPAL derived step counts
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Difference in changes from baseline to 3 months (post intervention/post waiting)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sedentary time
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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activPAL-derived sedentary time.
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Change from baseline at 3, 6, 9 and 12 months.
|
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Global Disability
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Functional mobility
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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Timed Up and Go Test (TUG)
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Gait Speed
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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10-meter walk test (10MWT)
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Change from baseline at 3, 6, 9 and 12 months.
|
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Walking Endurance
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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6-Minute walk test (6MWT)
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Change from baseline at 3, 6, 9 and 12 months.
|
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Self efficacy
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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Stroke Self Efficacy Questionnaire is a 13-item questionnaire.
Higher scores in each subscale indicate higher confidence levels and better self-efficacy.
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Change from baseline at 3, 6, 9 and 12 months.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Stanford Gender-Related Variables for Health Research scale
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
The Stanford Gender-Related Variables for Health Research scale is a 25-item self-report survey that measures how specific gender-related behaviors and roles impact physical and mental well-being.
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Cognition
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
5-minute Montreal Cognitive Assessment (5-min MoCA)
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Change from baseline at 3, 6, 9 and 12 months.
|
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Memory
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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Multifactorial Memory Questionnaire 9 (MMQ-9).
T scores will be derived.
T scores between 40 and 60 are generally interpreted as average.
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Change from baseline at 3, 6, 9 and 12 months.
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EuroQol-5 Dimension 5-Level (EQ-5D-5L)
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
The 5-level EQ-5D version (EQ-5D-5L) is a patient-reported quality of life measure.
Country-specific valuation set will be used.
The EQ-5D VAS score rates perceived health on a scale of 0-100, where higher scores are better.
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Change from baseline at 3, 6, 9 and 12 months.
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Depression
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire where higher scores represent worse outcome.
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Fatigue Severity Scale (FSS)
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
Fatigue Severity Scale (FSS) is a 9-item questionnaire with higher scores indicating worse outcome
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
|
Pittsburgh Sleep Quality Index (PSQI) scores range from 0 to 21 where higher scores are worse.
|
Change from baseline at 3, 6, 9 and 12 months.
|
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Modified Caregiver Stress Index
Periodo de tiempo: Change from baseline at 3, 6, 9 and 12 months.
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Modified Caregiver Stress Index is a 13-item questionnaire with higher scores indicating greater caregiver burden.
|
Change from baseline at 3, 6, 9 and 12 months.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
3 de agosto de 2026
Finalización primaria (Estimado)
30 de junio de 2030
Finalización del estudio (Estimado)
30 de junio de 2031
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00140017
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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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