- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02448030
Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals
18 de mayo de 2015 actualizado por: Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre
Effects of Functional Electrical Stimulation Compared to Isometric Exercise on Metaboreflex Activation in Healthy Individuals: Randomized Crossover Clinical Trial
Cardiovascular exercise adjustments are required during in order to redistribute blood flow from non-exercising vascular areas to active muscles.
This hemodynamic adjustments, which are partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990).
Static handgrip exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005) and activation of muscle metaboreflex that increases arterial blood pressure and peripheral vasoconstriction, respectively.
Functional electrical stimulation (FES) treatment used in physical therapy in patients who are unable to tolerate conventional exercise showed to be a good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic abnormalities (Karavidas, 2006).
However, the effect of FES on metaboreflex activation in healthy individuals has never been investigated.
Therefore, this study aims to evaluate the metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and also to compare their results with the effects caused by isometric exercise.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
All participants will be invited to attend four separate days for completion of the study protocols.
On the first day, the metaboreflex activation in upper limb will be randomly assigned to isometric exercise or FES intervention.
On the second day, at least two days apart, random isometric exercise or FES intervention will be performed in the upper limb.
On the third day, at least one week apart, all participants will be assigned to perform metaboreflex in a lower limb induced by isometric exercise or FES intervention.
On the fourth day, at least two days apart, random isometric exercise or FES intervention will be performed in a lower limb.
To evaluate the isometric exercise and FES intervention the post-exercise ischemia will be randomly performed to evaluate the accumulation of metabolites in response to activated limb (PECO +) and evaluation control without ischemia (PECO-).
The experiments between PECO+ and PECO- will be separated by a 30 min interval.
During isometric exercise and FES protocols the blood flow and peripheral vascular resistance will be assessed by venous occlusion plethysmography.
Fatigue will be determined every minute by the 10-point Borg scale to assess rate of perceived exertion and by blood lactate.
Blood lactate will be evaluated through capillary action at pre, immediately post exercise and at 5 minutes during the recovery period.
Hemodynamic variables such as BP and HR will be recorded every minute during the protocols.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
20
Fase
- Fase temprana 1
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: Beatriz Dr Schaan, PhD
- Número de teléfono: +55 5193138534
- Correo electrónico: beatrizschaan@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Aline Dr Macedo, Graduate
- Número de teléfono: +55 5197016966
- Correo electrónico: alinechagastelles@gmail.com
Ubicaciones de estudio
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RS
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Porto Alegre, RS, Brasil, 90035-003
- Reclutamiento
- Hospital de Clinicas de Porto Alegre
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Investigador principal:
- Beatriz Schaan, PhD
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Contacto:
- Aline Macedo, Graduate
- Número de teléfono: +55 51 97016966
- Correo electrónico: alinechagastelles@gmail.com
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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
35 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy individuals
- Both genders
- Aged 35-70 years
- Sedentary
- Not using continuous medications
Exclusion Criteria:
- Cardiovascular disease
- Neurological disease
- Malignant disease
- Peripheral vascular disorders (varicose veins or deep vein thrombosis)
- Peripheral sensitivity alterations
- Contraindication to performing physical exercise
- Refusal to sign the consent form
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 |
---|---|
Experimental: Functional electric stimulation
Other: The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.
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The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.
The stimulation frequency will be 20 Hz.
The pulse width used will be 0.5 milliseconds and the contraction time will be 60 seconds (TON: 60s) with a 1-second rest interval (TOFF: 1s).
The total time of application will be determined for the muscle fatigue that will be evaluated by 10-point Borg scale and by the measurement of lactate accumulation that must not exceed 30 minutes.
The intensity will be adjusted individually, taking into account the patient's ability to promote the full flexion of the wrist / knee extension and comfort during contractions.
Along with the application of FES a 1 Kg overload will be applied to intensify the fatigue time.
Otros nombres:
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Comparador de placebos: Isometric exercise
For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test.
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For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test.
For the lower limbs the knee extension exercise will be conducted in a training station.
The SBP, DBP, MBP and HR will be recorded through the protocols.
Fatigue will be determined every minute by the 10-point Borg scale and by measurement of lactate accumulation before, immediately after the protocol, and 5 minutes during the recovery period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Forearm and calf blood flow change
Periodo de tiempo: 5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
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When performed the protocol with FES measurements will be taken for 3 minutes of rest (in both PECO+ and PECO-), 5 minutes of exercise (when PECO-) or to fatigue (when PECO +), during the 3 minutes of occlusion (when PECO +) and 3 minutes final recovery (in both PECO+ and PECO-).
When performed the protocol with isometric exercise measurements will be at 3 minutes basal (in both PECO+ and PECO-), 3 minutes of exercise (in both PECO+ and PECO-), 3 minutes of occlusion when PECO + and 3 minutes of ultimate recovery (in both PECO+ and PECO-).
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5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum muscle strength
Periodo de tiempo: The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
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Before starting the evaluations of blood flow, the maximum peak strength is measured three times with 1 minute interval between each measurement, after is calculated 30% of the maximum value and the determined load exercise.
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The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
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Peripheral vascular resistance
Periodo de tiempo: It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
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Ratio between the mean arterial pressure (MBP) and muscle blood flow.
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It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Beatriz Dr Schaan, PhD, Hospital de Clinicas de Porto Alegre
- Silla de estudio: Aline Macedo, Graduate, Federal University of Rio Grande do Sul
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
- Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.
- Mitchell JH. J.B. Wolffe memorial lecture. Neural control of the circulation during exercise. Med Sci Sports Exerc. 1990 Apr;22(2):141-54. No abstract available.
- Rowell LB, O'Leary DS. Reflex control of the circulation during exercise: chemoreflexes and mechanoreflexes. J Appl Physiol (1985). 1990 Aug;69(2):407-18. doi: 10.1152/jappl.1990.69.2.407.
- Kim JK, Sala-Mercado JA, Rodriguez J, Scislo TJ, O'Leary DS. Arterial baroreflex alters strength and mechanisms of muscle metaboreflex during dynamic exercise. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1374-80. doi: 10.1152/ajpheart.01040.2004. Epub 2004 Nov 11.
- Karavidas AI, Raisakis KG, Parissis JT, Tsekoura DK, Adamopoulos S, Korres DA, Farmakis D, Zacharoulis A, Fotiadis I, Matsakas E, Zacharoulis A. Functional electrical stimulation improves endothelial function and reduces peripheral immune responses in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):592-7. doi: 10.1097/01.hjr.0000219111.02544.ff.
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
1 de marzo de 2015
Finalización primaria (Anticipado)
1 de diciembre de 2015
Finalización del estudio (Anticipado)
1 de marzo de 2016
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2015
Publicado por primera vez (Estimar)
19 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 14-0359
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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