Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
5 de junho de 2016 atualizado 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).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in dynamic balance and mobility from baseline
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in knee pain from baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ratio of number of exercise sessions attended to the maximum
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael A Hunt, PT, PhD, University of British Columbia
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2014
Conclusão Primária (Real)
1 de dezembro de 2015
Conclusão do estudo (Real)
1 de dezembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
1 de abril de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de abril de 2014
Primeira postagem (Estimativa)
4 de abril de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de junho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de junho de 2016
Última verificação
1 de junho de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H14-00587
- AHPA-TAS- 14-001 (Número de outro subsídio/financiamento: AHPA/The Arthritis Society)
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