The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee (GRADIT)
The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The principle objectives of managing OA are to control pain adequately, improve function and reduce disability. There is strong evidence that exercise therapy has a short term benefit for OA. However, these beneficial effects decrease over time and finally disappear. This decline is thought to be related to the difficulties people have in maintaining adherence to prescribed exercises. Therefore, to enhance long term benefit, adherence to exercise therapy is of utmost importance. Recently, the focus of attention within physiotherapy has shifted towards behaviorally oriented treatment, like Behavioral Graded Activity (BGA), which focuses less on pain and includes psychological and social factors in the treatment-process. Such intervention seems appropriate to increase the level of activities of patients with OA in a time-contingent way and to increase patients' adherence to these activities.
However, at the start of the present study the scientific evidence for the effectiveness of BGA in patients with a progressive and specific chronic disease, like OA of the hip and knee, was not available. Therefore, we performed a randomized controlled trial to study the effectiveness of BGA in patients with OA of the hip or knee. It was hypothesised that in the long term BGA results in less pain, less limitations in activities, and better patient global assessment (i.e. the effect of treatment perceived by patients themselves), compared to usual care of physiotherapists (UC). UC was operationalized as physiotherapeutic care according to the Dutch physiotherapy guideline for patients with hip and/or knee OA. It was also investigated whether specific subgroups of patients benefited more from BGA and which factors influenced the success of BGA-treatment. Also, it will be investigated whether differences exist in exercise adherence and whether there is a relationship between exercise adherence and long-term effectiveness.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Utrecht, Países Bajos, 3500 BN
- NIVEL
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology
Exclusion Criteria:
- other pathology explaining the complaints;
- complaints in less than 10 out of 30 days;
- treatment for these complaints with exercise therapy in the preceding six months;
- under 50 or over 80 years of age;
- indication for hip or knee replacement within one year;
- contraindication for exercise therapy;
- inability to understand the Dutch language;
- a high level of physical function (since patients who perform at a high level of physical function at baseline do not need to increase their level of physical function. A high level of physical function was operationalized on a score of less than two on the sections walking ability and physical function of the Algofunctional index)
Plan de estudios
¿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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Experimental: A
Behavioral graded activity
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The intervention is directed at increasing the level of activities in a time-contingent way, with the goal to integrate these activities in the daily living of the patients.
The intervention is performed by physical therapists in primary care, on individual basis.
Treatment period of maximal 12 weeks (with maximal 18 sessions), followed by 5 pre-set boostermoments with a maximum of 7 sessions (respectively in week 18, 25, 34, 42, and 55).
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Comparador activo: B
Exercise therapy
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Treatment according to the Dutch physiotherapy guideline for patients with osteoarthritis of hip and/or knee.
This guideline consists of general recommendations, emphasizing provision of information and advice, exercise therapy, and encouragement of a positive coping with the complaints.
The treatment consisted of a maximum of 18 sessions within a period of 12 weeks.
The treatment could be discontinued within the 12 week period if, according to the physiotherapists, all treatment goals were achieved.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Pain
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Physical function
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Patient global assessment
Periodo de tiempo: week 13, 39 and 65
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week 13, 39 and 65
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Tiredness
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Stiffness
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Joint mobility
Periodo de tiempo: week 0, 13, and 65
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week 0, 13, and 65
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Muscle strength
Periodo de tiempo: week 0, 13, and 65
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week 0, 13, and 65
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Patient-specific physical function
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Walking test
Periodo de tiempo: week 0, 13, and 65
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week 0, 13, and 65
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Pain coping
Periodo de tiempo: week 0, and 65
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week 0, and 65
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Locus of control
Periodo de tiempo: week 0 and 65
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week 0 and 65
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Quality of life
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Exercise adherence
Periodo de tiempo: week 13, 39 and 65
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week 13, 39 and 65
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Social support
Periodo de tiempo: week 0, and 65
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week 0, and 65
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Level of performed activities
Periodo de tiempo: week 0, 13, 39 and 65
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week 0, 13, 39 and 65
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Joost Dekker, PhD, VU Medical Center Amsterdam, The Netherlands
- Director de estudio: Johannes WJ Bijlsma, PhD, MD, UMC Utrecht, The Netherlands
- Investigador principal: Cindy Veenhof, PhD, NIVEL, Utrecht, The Netherlands
- Director de estudio: Cornelia HM van den Ende, PhD, St Maartenskliniek, Nijmegen, The Netherlands
- Investigador principal: Martijn FP Pisters, MSc, NIVEL, Utrecht, The Netherlands
Publicaciones y enlaces útiles
Publicaciones Generales
- Veenhof C, Koke AJ, Dekker J, Oostendorp RA, Bijlsma JW, van Tulder MW, van den Ende CH. Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: A randomized clinical trial. Arthritis Rheum. 2006 Dec 15;55(6):925-34. doi: 10.1002/art.22341.
- Veenhof C, van Hasselt TJ, Koke AJ, Dekker J, Bijlsma JW, van den Ende CH. Active involvement and long-term goals influence long-term adherence to behavioural graded activity in patients with osteoarthritis: a qualitative study. Aust J Physiother. 2006;52(4):273-8. doi: 10.1016/s0004-9514(06)70007-1.
- Coupe VM, Veenhof C, van Tulder MW, Dekker J, Bijlsma JW, Van den Ende CH. The cost effectiveness of behavioural graded activity in patients with osteoarthritis of hip and/or knee. Ann Rheum Dis. 2007 Feb;66(2):215-21. doi: 10.1136/ard.2006.054478. Epub 2006 Jul 31.
- Veenhof C, Dekker J, Bijlsma JW, van den Ende CH. Influence of various recruitment strategies on the study population and outcome of a randomized controlled trial involving patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2005 Jun 15;53(3):375-82. doi: 10.1002/art.21171.
- Pisters MF, Veenhof C, de Bakker DH, Schellevis FG, Dekker J. Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial. J Physiother. 2010;56(1):41-7. doi: 10.1016/s1836-9553(10)70053-9.
- Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis Cartilage. 2010 Aug;18(8):1019-26. doi: 10.1016/j.joca.2010.05.008. Epub 2010 May 19.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- GRADIT-01
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