Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
12 de febrero de 2014 actualizado por: University of Florida
Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.
Descripción general del estudio
Estado
Terminado
Tipo de estudio
Intervencionista
Inscripción (Actual)
72
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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Florida
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Gainesville, Florida, Estados Unidos, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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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
60 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- chronic low back pain for >6 months
- >3 pain episodes per week
- waist circumferences ≥102 cm for men
- waist circumferences ≥ 88 cm for women
- willing and able to participate in regular exercise for 14 weeks
- using pain medications to control low back pain
- free of abnormal cardiovascular responses during a screening graded maximal walk test
Exclusion Criteria:
- unable to walk
- participating in regular resistance exercise training (>3X week) in the past 6 months
- pain symptoms are too severe and prevent strength testing or walking
- acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- back surgery within the past 2 years
- current use of weight loss interventions (drugs; exercise interventions)
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
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physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines
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Comparador activo: Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
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lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months
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Comparador activo: Total Body Resistance Exercise Program
Training protocol for 1 set for each exercise: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl
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exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3 and 4 Months
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The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable.
Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
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Baseline, 1, 2, 3 and 4 Months
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Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3 and 4 Months
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Fear avoidance beliefs will be measured using the 11 item TSK.
Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
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Baseline, 1, 2, 3 and 4 Months
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Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baselinje, 1, 2, 3 and 4 Months
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The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain.
Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
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Baselinje, 1, 2, 3 and 4 Months
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Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3 and 4 Months
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The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness.
Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.
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Baseline, 1, 2, 3 and 4 Months
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Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3 and 4 Months
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The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures.
Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
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Baseline, 1, 2, 3 and 4 Months
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Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3, and 4 Months
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The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures.
Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
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Baseline, 1, 2, 3, and 4 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Graded Treadmill Exercise Test; Change from Baseline at 4 Months
Periodo de tiempo: Baseline and 4 Months
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Maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test.
Subjects will complete the exercise test at the indicated time intervals to document any change in their aerobic fitness.
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Baseline and 4 Months
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Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
Periodo de tiempo: Baseline and 4 Months
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Chair rise time will be measured as the participant moves from a sitting to a full standing position.
The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 12 steps as quickly as possible.
Gait will be assessed by having the participants walk across a 26' portable walkway.
Subjects will complete these motions at the indicated time intervals to document any change.
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Baseline and 4 Months
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7-day Pedometer Test; Change from Baseline at 4 Months
Periodo de tiempo: 7 day period at Baseline and 4 Months
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Community ambulation will be estimated using a 7-day pedometer test in which participants will wear a StepWatch® step activity monitor.
Subjects will complete this test at the indicated time intervals to document any change in their ambulation.
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7 day period at Baseline and 4 Months
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Ultrasound Muscle Thickness; Change from Baseline at 4 Months
Periodo de tiempo: Baseline and 4 Months
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The ultrasound technique that will be used to capture muscle thickness changes in the paraspinal and multifidus muscles.
Subjects will be tested at the indicated time intervals to document any change.
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Baseline and 4 Months
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Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
Periodo de tiempo: Baseline, 1, 2, 3 and 4 Months
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Assessments of strength (1 repetition maximum, 1-RM) will be determined for all muscle groups trained.
Subjects will be assessed at the indicated time intervals to document any change.
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Baseline, 1, 2, 3 and 4 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 noviembre de 2010
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
5 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
29 de noviembre de 2010
Publicado por primera vez (Estimar)
30 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
12 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 258-2010
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