Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Forced Aerobic Exercise for Stroke Rehabilitation

20 de dezembro de 2018 atualizado por: Susan Linder, The Cleveland Clinic
The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The goal of this study is to determine the potential for forced aerobic exercise to augment the recovery of motor function in individuals with stroke. Current approaches to stroke rehabilitation involve intensive, therapist-directed task practice that is both expensive and in some cases, ineffective in fostering functional neuromotor recovery. The identification of a safe, cost-effective approach, such as forced aerobic exercise, to augment the recovery of function achieved through task practice while simultaneously decreasing the cardiovascular risk factors prevalent in stroke survivors would be significant to rehabilitation and stroke communities.

Animal studies along with preliminary human data indicate a specific type of aerobic exercise (AE), forced aerobic exercise (FE), may be ideal in facilitating motor recovery associated with repetitive task practice (RTP). The hypothesis is that that deficits in afferent input and motor cortical output following stroke prevents patients from achieving and maintaining an exercise intensity that is sufficient for facilitating motor recovery; therefore, FE is needed to augment their voluntary efforts and achieve greater gains in recovery. In previous research, a safe lower extremity FE intervention was initially applied to individuals with Parkinson's disease and subsequently to individuals with stroke. Preliminary results indicate that those completing an 8-week FE intervention paired with an abbreviated session of RTP exhibited significantly greater improvement in Fugl-Meyer scores at end of treatment despite completing 40% fewer RTP repetitions, compared to those receiving voluntary-rate aerobic exercise (VE) and RTP and time-matched RTP only. Improvements in cardiovascular fitness and lower extremity motor function were also evident in both groups that engaged in aerobic exercise (FE and VE). Positive results from a preliminary trial indicate safety, feasibility, and initial efficacy of combining two modes of aerobic exercise training with RTP provide rationale for a systematic and larger scale trial to determine the precise role of aerobic exercise, forced and voluntary, in facilitating motor recovery following stroke.

For this study, 30 individuals with chronic stroke will be randomized into one of the following groups: FE = RTP, VE + RTP or patient education and RTP. All three groups will receive an identical dose of contact time over 8 weeks (3X per week). An intervention group receiving a 45-minute session of patient education paired with RTP will serve as the non-exercise control. Clinical and biomechanical outcomes measuring change in upper extremity motor function, lower extremity motor function, and cardiovascular fitness will provide the most complete picture, to date, on the potential neurologic effects of AE (forced and voluntary) on motor recovery and brain function in humans with stroke.

Tipo de estudo

Intervencional

Inscrição (Real)

34

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

  • Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic

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

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Able to provide informed consent
  • At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging
  • Fugl-Meyer Motor Score 19-55 in involved upper extremity
  • Approval from patient's physician
  • Age between 18 and 85 years

Exclusion Criteria:

  • Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
  • Serious cardiac arrhythmia
  • Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)
  • Other medical or musculoskeletal contraindication to exercise
  • Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
  • Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
  • Pregnancy
  • Unstable blood pressure at rest or with exercise

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
Comparador Ativo: Forced Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
  2. 45 minutes of upper extremity repetitive arm exercises
Comportamental: Forced Exercise & Upper Extremity Repetitive Task Practice
Comparador Ativo: Voluntary Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
  2. 45 minutes of upper extremity repetitive arm exercises
Comportamental: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Comparador Ativo: Stroke Education & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of stroke education
  2. 45 minutes of upper extremity repetitive arm exercises
Comportamental: Stroke Education & Upper Extremity Repetitive Task Practice

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fugl Meyer Assessment
Prazo: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Wolf Motor Function Test
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Stroke Impact Scale
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Metabolic Stress Test
Prazo: Change from baseline to follow up assessments at end of 8 week intervention
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Change from baseline to follow up assessments at end of 8 week intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Action Research Arm Test
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Center for Epidemiological Studies-Depression
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Processing Speed Test
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Nine Hole Peg Test
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Six Minute Walk Test
Prazo: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Cleveland Clinic

Colaboradores

American Heart Association

Investigadores

  • Investigador principal: Susan Linder, PT, DPT, NCS, The Cleveland Clinic

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 julho de 2015

Conclusão Primária (Real)

1 de agosto de 2017

Conclusão do estudo (Real)

1 de agosto de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2015

Primeira postagem (Estimativa)

10 de julho de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de março de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de dezembro de 2018

Última verificação

1 de dezembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 12-402

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 .

Se inscrever