- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07692191
Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kristine C Cowley, PhD
- Número de teléfono: +1 204-789-3305
- Correo electrónico: kristine.cowley@umanitoba.ca
Copia de seguridad de contactos de estudio
- Nombre: Rodrigo Villar, PhD
- Número de teléfono: +1-204-474-8590
- Correo electrónico: rodrigo.villar@umanitoba.ca
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0J9
- Reclutamiento
- University of Manitoba
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Contacto:
- Kristine Cowley, PhD
- Número de teléfono: +1-204-789-3305
- Correo electrónico: kristine.cowley@umanitoba.ca
-
Investigador principal:
- Kristine Cowley, PhD
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Investigador principal:
- Rodrigo Villar, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- traumatic or non-traumatic spinal cord injury
- Spinal cord injury of at least one year duration, C5 or lower, AIS A - D
- medically stable and healthy enough to engage in and complete exercise requirements
- willing and able to complete the exercise protocols and testing requirements
- able to understand and follow written and verbal instructions from study staff
- able to communicate with study staff about their exercise capabilities and preferences
Exclusion Criteria:
- current serious injury (ies) of the upper extremities
- known cardiovascular disease
- unsatisfactory results of EKG screening
- implanted electronic cardiac devices (e.g., pacemaker, defibrillator, etc.)
- current pressure ulcer(s)
- morbid obesity
- known thyroid dysfunction
- current cancer
- current uncontrolled high blood pressure
- uncontrolled epilepsy
- current deep vein thrombosis
- ventilator dependency
- cognitive impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Upper body exercise in participants with tetraplegia
TSES during peak and steady state exercise in those with tetraplegia
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TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
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Otro: Upper body exercise in participants with paraplegia
TSES during peak and steady state exercise in those with paraplegia
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TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Otro: Upper body exercise in reference control participants
TSES during peak and steady state exercise in reference controls
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TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Otro: Rhythmic lower limb neuromuscular electrical stimulation evoked exercise
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
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TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Oxygen uptake
Periodo de tiempo: During individual study visits lasting between 1 and 2.5 hours
|
Oxygen uptake, in mL/min
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During individual study visits lasting between 1 and 2.5 hours
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Perceived Exertion
Periodo de tiempo: Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
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Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
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Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
|
Time to fatigue during incremental exercise tests to fatigue
Periodo de tiempo: Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
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Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
|
Heart rate
Periodo de tiempo: During exercise testing study visits, lasting between 1 and 3 hours
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Heart rate, beats per minute
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During exercise testing study visits, lasting between 1 and 3 hours
|
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Power output
Periodo de tiempo: During exercise in study visits lasting 1 to 3 hours.
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Watts
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During exercise in study visits lasting 1 to 3 hours.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle tissue oxygen saturation levels
Periodo de tiempo: Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
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Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristine Cowley, Phd, University of Manitoba
- Investigador principal: Rodrigo Villar, PhD, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Lesiones de espalda
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Enfermedades cardiovasculares
- Lesiones de la médula espinal
- Lesiones de la médula
- Actividad del motor
Otros números de identificación del estudio
- HS26003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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