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- Ensaio Clínico NCT02350387
Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Arthritis is the leading cause of disability in the United States. Osteoarthritis (OA) is the most common type of arthritis and affects nearly 27 million Americans. Knee OA is the most common type of osteoarthritis and is estimated to affect 42.1% of women and 31.2% of men over the age of 60.
Osteoarthritis is most likely multi-factorial with several underlying causes. It is no longer considered "a degenerative joint disease" but rather a process that involves dynamic biomechanical, biochemical, and cellular processes. It not only involves degeneration of the articular cartilage, but also inflammation of the synovium, changes to the underlying subchondral bone, and the development of osteophytes. Currently, it appears that numerous systemic factors can lead to the initiation of OA through different causal pathways . These systemic causes can then be amplified by local factors such as trauma or increased loading caused by obesity.
Currently, there is no "cure" for OA and attempts to find a disease modifying drug have been unsuccessful. Thus, treatment currently focuses on mitigating factors that are known to affect the radiographic progression of the disease as well as lead to activity limitation and participation restriction.9,10 Decreases in lower extremity strength are a major cause of activity limitations given the vital role of strength in activities of daily living.
One method that is used to mitigate progressing factors is through the use of an exercise program. Many types of exercise have been used successfully in the literature including resistance training. Resistance training can take many different forms such as isometric, isotonic (concentric and/or eccentric) or isokinetic with various intensities. Presently, there is little evidence for the use of eccentric training interventions for patients with knee OA. This study aims to further examine this type of resistance training for the OA population. Therefore, the purpose of this study is to examine the effects of low intensity, long duration eccentric resistance training and high intensity, short duration eccentric resistance training in individuals with knee OA. Ideally, this study will allow us to determine the overall effects of eccentric resistance training as well as the potential differences of the two types of eccentric resistance training.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80221
- Regis University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Individuals will be included in the study if they are:
- at least 55 years old,
- cognitively able to understand directions,
- able to ambulate at least 50 feet without stopping,
- are currently experiencing knee pain and
- meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR) criteria for knee osteoarthritis diagnosis.
Exclusion Criteria:
Individuals will be excluded from the study if they have:
- a diagnosed medical condition that would limit physical ability, including acute or active fractures, myocardial infarctions, stroke,
- a traumatic brain injury within the last 6 months, or
- joint replacement within the last 12 months. Individuals with chronic neurological disorders limiting motion or present with any known contraindication for balance training will also be excluded from the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: High Intensity Short Duration Exercise
Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
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Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
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Experimental: Low Intensity Long Duration Exercise
Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
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Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
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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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Isometric quadriceps strength as measured by a hand held dynamometer
Prazo: Change from baseline to 8 weeks
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The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.
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Change from baseline to 8 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lower extremity muscle strength as measured by a hand held dynamometer
Prazo: Change from baseline to 8 weeks
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Trunk flexion/extension, Hip Abduction/Extension, Knee Flexion/Extension, and Ankle Plantarflexion and Dorsiflexion will be assessed at baseline and 8 weeks by a hand held dynamometer.
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Change from baseline to 8 weeks
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Timed Up and Go Test
Prazo: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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|
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6-minute Walk Test
Prazo: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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Five times sit to stand test
Prazo: Change from baseline to 8 weeks
|
Change from baseline to 8 weeks
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Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)
Prazo: Change from baseline to 8 weeks
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Balance will be assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test.
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Change from baseline to 8 weeks
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Arthritis Impact Measurement Scale (AIMS)
Prazo: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)
Prazo: At the beginning of every treatment session and following every treatment session for the 8 week intervention
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Pain and muscle soreness will be assessed utilizing a numeric pain rating scale at the beginning and end of every treatment session.
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At the beginning of every treatment session and following every treatment session for the 8 week intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael J Bade, PT, PhD, Regis University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças articulares
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Artrite
- Osteoartrite
- Osteoartrite, Joelho
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Alfa-Agonistas Adrenérgicos
- Agonistas Adrenérgicos
- Agentes do Sistema Respiratório
- Simpaticomiméticos
- Agentes vasoconstritores
- Descongestionantes Nasais
- Oximetazolina
Outros números de identificação do estudo
- 15-010
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .