- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01805479
Exercise Training in Depressed Traumatic Brain Injury Survivors
18 de dezembro de 2015 atualizado por: Virginia Commonwealth University
The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.
Visão geral do estudo
Status
Retirado
Condições
Intervenção / Tratamento
Descrição detalhada
Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts.
Sequelae of TBI includes depression in up to 30% of cases.
Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society.
Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal.
Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population.
Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required.
This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.
Tipo de estudo
Intervencional
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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Virginia
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Richmond, Virginia, Estados Unidos, 23298-0568
- Virginia Commonwealth University
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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
14 anos a 65 anos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
- Glasgow outcome scale extended of 4 to 8
- speaks English
- Beck Depression Inventory -II score between 14 and 28
- sedentary life style
- one to three years after traumatic brain injury
Exclusion Criteria:
- prior history of brain process (example, stroke, brain tumor)
- aphasia
- psychosis, mania, bipolar disorder, schizophrenia
- pregnancy
- inability to exercise via cycles or treadmill
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
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador de Placebo: stretching-flexibility
This group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity.
It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm.
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stretching and flexibility program for the Placebo Comparator Arm
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Comparador Ativo: aerobic exercise group
aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.
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the active arm will be asked to perform 60% of maximum heart rate
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
completion of exercise protocol
Prazo: 12 weeks
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The primary aim is to measure the rate of completion of the exercise protocol.
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
neuropsychological testing
Prazo: pre and post intervention, week zero and week 13
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cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects.
Administered to both arms.
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pre and post intervention, week zero and week 13
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mood assessment
Prazo: week 0, week 13, and weekly during 12 week intervention
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depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects.
Administered to both arms.
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week 0, week 13, and weekly during 12 week intervention
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Columbia-Suicide Severity Rating Scale
Prazo: week 0, week 13, and weekly during 12 week intervention
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Columbia-Suicide Severity Rating Scale was developed to meet the need for tracking changes in a person's suicidal thinking and behavior over time, and to determine who is most at risk.
Administered to both arms.
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week 0, week 13, and weekly during 12 week intervention
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magnetic resonance imaging
Prazo: week 0, week 13
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MRI will be done before and after exercise protocol on a subset of subjects.
Selection of these subjects will be done by randomization, starting once the MRI is available for use.
The purpose is to examine the brain for exercise influenced volumetric changes.
Administered to a subset of both arms of the study.
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week 0, week 13
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biochemical assays
Prazo: week 0, week 13
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brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor-1.
The listed neurotrophic factors have been linked to depression and have been shown to be influenced by exercise.
The impact of depression and exercise in the context of traumatic brain injury is unknown.
Administered to both study arms.
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week 0, week 13
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anne Hudak, MD, Virginia Commonwealth University
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
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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 fevereiro de 2013
Conclusão Primária (Real)
1 de junho de 2014
Conclusão do estudo (Real)
1 de junho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
1 de março de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2013
Primeira postagem (Estimativa)
6 de março de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de dezembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de dezembro de 2015
Última verificação
1 de dezembro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PT107574
- 7K23HD067553 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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 .
Ensaios clínicos em stretching and flexibility program
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis ObispoConcluídoConsumo de frutas e vegetais | Nutrição infantil | Escolha de comida saudável | Preparação de Alimentos SaudáveisEstados Unidos
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Haukeland University HospitalUniversity of Bergen; Norwegian University of Science and Technology; St. Olavs... e outros colaboradoresRecrutamentoTranstorno do Espectro AutistaNoruega