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Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease

18 de mayo de 2018 actualizado por: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul

Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.

Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes joint inflammation and progressive joint destruction. Rheumatoid cachexia is one of the structural manifestations of RA, and consists of a reduction in muscle mass, due to an increased muscle protein catabolism induced by inflammatory cytokines. This muscle mass loss generates an impairment in physical function and functional capacity in RA patients. The aim of study was to verify neuromuscular and functional responses in middle-aged women with RA compared to paired healthy women.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Actual)

70

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

25 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

35 RA patients (class I and II according American Rheumatism Association) and 35 healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).

Descripción

Inclusion Criteria:

  • RA patients with a class I and II RA diagnosis according to the American Rheumatism Association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic.

Exclusion Criteria:

  • presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Rheumatoid Arthritis Patients
Forty women (range 25-75 years), with a class I and II RA diagnosis according to the American Rheumatism Association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic. Exclusion criteria included the presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility. Five patients were excluded for not attending the inclusion criteria, leading to a final number of 35 RA patients.

The Timed Up and Go test; Maximal knee-extensor muscle strength (isometric and concentric tests) was measured with a Biodex System 3 dynamometer; A B-mode ultrasonography system with a linear-array probe (60 mm, 7.5 MHz) was used to determine VL and RF muscle thickness, pennation angle, fascicle length and tendon CSA. Measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion.

An 8-channel EMG system was synchronized with the dynamometer through a Windaq data acquisition system and used to evaluate the vastus lateralis and rectus femoris electrical activity during isometric knee-extensor tests.

Healthy Women
Thirty-five healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).

The Timed Up and Go test; Maximal knee-extensor muscle strength (isometric and concentric tests) was measured with a Biodex System 3 dynamometer; A B-mode ultrasonography system with a linear-array probe (60 mm, 7.5 MHz) was used to determine VL and RF muscle thickness, pennation angle, fascicle length and tendon CSA. Measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion.

An 8-channel EMG system was synchronized with the dynamometer through a Windaq data acquisition system and used to evaluate the vastus lateralis and rectus femoris electrical activity during isometric knee-extensor tests.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Knee-Extensor Muscular Strength
Periodo de tiempo: Only one day.
Maximal knee-extensor muscle strength (isometric and concentric tests), in different angles and velocities were measured with a Biodex System 3 dynamometer (Biodex Medical Systems, Shirley, NY, USA). A 2-min interval was observed between contractions. We used the peak torque of each maximal test to analysis.
Only one day.
Muscle architecture and tendon parameters
Periodo de tiempo: Only one day.
An ultrasonography system was used to determine VL and RF muscle thickness, pennation angle and fascicle length. Muscle architecture measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion. Muscle thickness was considered the distance between deep and superficial aponeuroses. The best fascicle in each image was used for pennation angle and fascicle length analysis. Pennation angle was calculated as the angle between the muscle fascicle and the deep aponeurosis, whereas fascicle length was measured as the length of the fascicular path between the two aponeuroses. Furthermore, patellar tendon cross-section area was measured with probe perpendicular to tendon during isometric contractions.
Only one day.
Functional Capacity
Periodo de tiempo: Only one day.
Timed Up and Go test
Only one day.
Quadriceps muscle activation
Periodo de tiempo: Only one day.
Vastus Lateralis and Rectus Femoris muscle activation during strength tests
Only one day.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 2013

Finalización primaria (Actual)

20 de noviembre de 2013

Finalización del estudio (Actual)

3 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2018

Publicado por primera vez (Actual)

1 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

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. .

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