Exercise Therapy Program in Ankylosing Spondylitis Patients
27 de agosto de 2016 actualizado por: Andrea Lopes Gallinaro, University of Sao Paulo
Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity.
So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients.
Methods.
Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) <4 were included.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The AS patients were randomly assigned into three groups, to receive a mobility exercise program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C).
The exercises group sessions were conducted twice per week for 16 weeks.
This supervised program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and limbs (M).
After the flexibility program, M+R group carry out more 30 minutes of elastic resistance exercises.
The mobility, disease activity and functional parameters were evaluated at baseline and after 16 weeks, with the evaluator blinded to the treatment group.
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
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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-
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Sao Paulo, Brasil, 05403-010
- University of Sao Paulo
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Ankylosing spondylitis patient
- Basdai index lower than 4
- Physical inactive
- Functional class I to III
Exclusion Criteria:
- Fibromyalgia
- Cardiovascular disease
- Pain Visual Analogue Scale ("VAS") over 8
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 |
|---|---|
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Sin intervención: ankylosing spondylitis control
control group
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Experimental: mobility exercise
mobility exercises
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30 minutes, twice a week
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Experimental: mobility and elastic resistance exercise
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
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30 minutes, twice a week each exercises group.
(total 1 hour)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
FUNCTIONAL INDEX
Periodo de tiempo: Baseline and 16 Weeks
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BASFI - Bath ankylosing spondylitis functional index.
A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.
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Baseline and 16 Weeks
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Mobility Index
Periodo de tiempo: Baseline and 16 weeks
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Bath ankylosing spondylitis motion index.
A mean of five mobility measures committed by Ankylosing Spondylitis disease.
Higher results means higher limitations in mobility (units of measure from 0 to 10)
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Baseline and 16 weeks
|
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Disease Activity Index
Periodo de tiempo: Baseline and 16 Weeks
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BASDAI - Bath ankylosing spondylitis disease activity index.
Scale from 0 to 6. Higher scores means worst disease activity.
Numbers are expressed in average (SD)
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Baseline and 16 Weeks
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Ankylosing Spondylitis Disease Activity Scale -Disease Activity
Periodo de tiempo: Baseline and 16 Weeks
|
Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity.
Data are expressed by means and SD
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Baseline and 16 Weeks
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Global Evaluation Self Reported
Periodo de tiempo: Baseline and 16 Weeks
|
Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation.
Expressed by means and standard deviation.
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Baseline and 16 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Thoracolumbar Mobility
Periodo de tiempo: Baseline and 16 Weeks
|
Thoracolumbar rotation Pavelka.
Measured with a tape in centimeters.
Higher number means better thoracolumbar rotation
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Baseline and 16 Weeks
|
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Pain Scale
Periodo de tiempo: Baseline and 16 Weeks
|
Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain.
Data was expressed by means and standard deviation.
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Baseline and 16 Weeks
|
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Stiffness Scale
Periodo de tiempo: Baseline and 16 Weeks
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Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness.
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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Short Form-12 (PCS)
Periodo de tiempo: Baseline and 16 Weeks
|
Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale.
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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Short Form-12 (MCS)
Periodo de tiempo: Baseline and 16 Weeks
|
Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health).
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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MASES
Periodo de tiempo: Baseline and 16 Weeks
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Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13.
Where 0 is no painful point reported and 13 is all tender points reported as painful.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Chin-coronoid Distance
Periodo de tiempo: Baseline and 16 Weeks
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lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters.
Highest score means better lateral rotation mobility.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Tragus-coronoid Distance
Periodo de tiempo: Baseline and 16 Weeks
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lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters.
Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Finger Floor Distance
Periodo de tiempo: Baseline and 16 Weeks
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Distance between third finger of the hand and the floor while in lumbar flexion.
It was measured with a tape in centimeters.
Highest score means better torso flexion mobility.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Chest Expansion
Periodo de tiempo: Baseline and 16 Weeks
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Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling.
Highest score means better chest expansion.
Data are expressed by means and standard deviation.
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Baseline and 16 Weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Ana Lucia Pinto, Phd, University of Sao Paulo
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.
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 julio de 2012
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
20 de septiembre de 2012
Publicado por primera vez (Estimar)
21 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8206212
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
paper is been written
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