Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
5 de junio de 2016 actualizado por: University of British Columbia
The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults.
Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA.
There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results.
Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function.
If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life.
The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA.
This will be a randomized controlled trial (RCT).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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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British Columbia
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Vancouver, British Columbia, Canadá, V6T 1Z3
- Motion Analysis and Biofeedback Laboratory, The University of British Columbia
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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
50 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
- predominance of pain/tenderness over the medial (inside) region of the knee
Exclusion Criteria:
- articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- inflammatory arthritic condition
- history of knee or hip replacement surgery
- recent use of corticosteroids (oral or via injection, within last 6 months)
- pain originating predominantly from the patellofemoral joint
- inability to ambulate without a gait aid
- non-English speaking
- recent (within 6 months) arthroscopic knee surgery
- significant hip or back pain (limits the ability to perform the testing)
- Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
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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Sin intervención: Wait list
Wait list control group.
Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period.
Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks).
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Experimental: Treatment (balance training)
Targeted dynamic balance training.
Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception.
Exercises will be performed four times per week for ten weeks.
Exercises will be taught and supervised by a trained kinesiologist.
Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises.
Exercises will be progressed to different exercises in each new phase (total 3 phases).
Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week.
All other sessions will be performed at home.
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Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks.
Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete.
Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in dynamic balance and mobility from baseline
Periodo de tiempo: 0, 10 weeks
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The Community Balance and Mobility Scale (CB&M) will be used to assess dynamic balance and mobility.
The CB&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor.
The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
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0, 10 weeks
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Change in self-reported physical function from baseline
Periodo de tiempo: 0, 10 weeks
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The Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function.
The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
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0, 10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in knee pain from baseline
Periodo de tiempo: 0, 10 weeks
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Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
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0, 10 weeks
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Change in fear of pain from baseline
Periodo de tiempo: 0, 10 weeks
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The Brief Fear of Movement Scale will be used to assess fear of pain.
This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury.
The scale has been validated in individuals with OA.
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0, 10 weeks
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Change in self-reported physical activity level from baseline
Periodo de tiempo: 0, 10 weeks
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The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level.
This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
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0, 10 weeks
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Change in knee joint proprioception from baseline
Periodo de tiempo: 0, 10 weeks
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Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception.
Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
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0, 10 weeks
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Change in muscle strength from baseline
Periodo de tiempo: 0, 10 weeks
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Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
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0, 10 weeks
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Change in knee joint range of motion from baseline
Periodo de tiempo: 0, 10 weeks
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Range of motion will be measured using a goniometer, similar to other studies of knee OA.
Participants will be asked to flex and extend their knee joint while supine.
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0, 10 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Ratio of number of exercise sessions attended to the maximum
Periodo de tiempo: 10 weeks
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Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.
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10 weeks
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Number of participants with adverse events
Periodo de tiempo: 10 weeks
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Adverse events experienced due to the intervention (i.e.
increased knee pain) will be recorded weekly by participants.
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10 weeks
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Change in medication use
Periodo de tiempo: 10 weeks
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Any change in pharmacological use by participants will be recorded.
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10 weeks
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Change in co-interventions
Periodo de tiempo: 10 weeks
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Other therapies that participants may be pursuing will be recorded.
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10 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael A Hunt, PT, PhD, University of British Columbia
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 junio de 2014
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
1 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
1 de abril de 2014
Publicado por primera vez (Estimar)
4 de abril de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de junio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
5 de junio de 2016
Última verificación
1 de junio de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H14-00587
- AHPA-TAS- 14-001 (Otro número de subvención/financiamiento: AHPA/The Arthritis Society)
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