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- Ensayo clínico NCT03709095
Sprint Interval Training During Rehabilitation After Spinal Cord Injury (SprintSCI)
15 de octubre de 2018 actualizado por: McMaster University
Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting.
The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week.
Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time.
Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT.
However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation.
The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation.
It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment.
It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
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
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Ontario
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Hamilton, Ontario, Canadá, L8S 4L8
- McMaster University
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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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)
- Undergoing inpatient rehabilitation
- Aged 18-65 years
- Injury level at the second cervical vertebrae (C2) or below
Exclusion Criteria:
- Unable to perform arm-ergometry training
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Moderate Intensity Continuous Training
Training was performed three times a week for five weeks.
Each session began with a 2 minute warm up, and concluded with a 3 minute cool down.
Following the warm-up, participants performed 20 minutes of arm cycling at a self-selected cadence at 45-65% of their peak power output.
Total training duration was 25 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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Experimental: Sprint Interval Training
The SIT protocol was adopted from Gillen and colleagues (See Ref), and consisted of 3 x 20 second "all-out" efforts at ≥ 100% of an individuals peak power output.
Each sprint was interspersed by 120 seconds of active recovery at 10% of an individuals peak power output.
Total training duration was 10 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in peak power output
Periodo de tiempo: Change in peak power output from baseline to 5 weeks
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maximum amount of power produced during a graded exercise test on the arm-ergometer
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Change in peak power output from baseline to 5 weeks
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Change in sub-maximal arm-ergometry
Periodo de tiempo: Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Participants performed three 5-minute steady state workloads on the arm-ergometer at power outputs corresponding to RPE's of 8, 10 and 12. Participants were given a minimum of 2 minutes, and a maximum of 5 minutes of rest in between each workload.
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Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cardiovascular Responses
Periodo de tiempo: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored heart rate throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Perceptual Responses
Periodo de tiempo: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored ratings of perceived exertion throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Change in self-efficacy for exercise
Periodo de tiempo: Change in self-efficacy from baseline to 5 weeks
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Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.
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Change in self-efficacy from baseline to 5 weeks
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Exercise Satisfaction
Periodo de tiempo: Measured only at the end of the intervention (5 weeks)
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Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
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Measured only at the end of the intervention (5 weeks)
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Pain perceptions
Periodo de tiempo: Measured only at the end of the intervention (5 weeks)
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Through a questionnaire, participants rated how much shoulder pain, bodily pain, and physical discomfort they typically experience throughout the day and how much pain they experienced with the intervention they were allocated to.
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Measured only at the end of the intervention (5 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Audrey L Hicks, PhD, McMaster 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
- Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.
- Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.
- Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.
- Astorino TA, Thum JS. Within-session responses to high-intensity interval training in spinal cord injury. Disabil Rehabil. 2018 Feb;40(4):444-449. doi: 10.1080/09638288.2016.1260648. Epub 2016 Dec 8.
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 junio de 2017
Finalización primaria (Actual)
1 de junio de 2018
Finalización del estudio (Actual)
1 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
11 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
15 de octubre de 2018
Publicado por primera vez (Actual)
17 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
15 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SprintSCI
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
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. .