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- Ensaio Clínico NCT04030390
The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population
The Influence of Acute Physical Fatigue on Different Balance Tests and Brain Activity During These Balance Tests in a Healthy Population
The main objective of this project is:
1. To assess the influence of physical fatigue on brain functioning during a balance and reaction time task in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).
The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked.
Next, the subjects will carry out a Y-balance test and a balance reaction-time test. Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same Y-balance test and balance reaction time test, and fill in the SRPE scale one more time. Heart frequency and EEG will be measured continuously during the trials.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Brussels, Bélgica, 1050
- Vrije Universiteit Brussel
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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:
- Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Exclusion Criteria:
- Back and/or lower extremity injuries during the past 6 months
- Bone/joint abnormalities
- Dizziness, history of loss of consciousness, any inner ear disorders
- Nervous system disorders or dysfunctions
- Uncorrected eye disorders/dysfunctions
- Illness
- Use of medication or any kind of drugs
- Use of alcohol, caffeine and heavy efforts 24 hours before each trial
- Not eating the same meal the night before and the morning of each experimental trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Condição de controle
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tarefa de tempo combinado (sentado na bicicleta sem pedalar)
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Experimental: Condição de Fadiga Física
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Esforço máximo de ciclismo por 30s (modificado por Wingate)
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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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Teste de tempo de reação de equilíbrio
Prazo: Alteração no desempenho do equilíbrio e do tempo de reação: desde a linha de base e 20 minutos após a linha de base (imediatamente após as intervenções designadas)
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Desempenho de equilíbrio e tempo de reação; os participantes devem manter o equilíbrio enquanto reagem o mais rápido possível em 3 direções diferentes.
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Alteração no desempenho do equilíbrio e do tempo de reação: desde a linha de base e 20 minutos após a linha de base (imediatamente após as intervenções designadas)
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Y-balance test
Prazo: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions
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Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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EEG power spectrum analysis
Prazo: Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Brain activity during the Y-balance test and balance-reaction time test will be registered at baseline and immediately after the assigned interventions.
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Change in EEG power spectrum: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Motivação autorreferida
Prazo: Na linha de base: antes da primeira bateria de testes
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Medida subjetiva de motivação avaliada com a escala de autoavaliação de motivação de Matthews et al. 4 = motivação máxima].
Cada construto contém 7 perguntas).
|
Na linha de base: antes da primeira bateria de testes
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Mental fatigue Visual Analogue Scale (M-VAS)
Prazo: Change in M-VAS: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests)
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Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
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Change in M-VAS: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final 2 balance tests)
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Perception of effort (Session RPE)
Prazo: Change in session RPE: at baseline (immediately after the first two balance tests), and 15 min after baseline (immediately after the final 2 balance tests)
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Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
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Change in session RPE: at baseline (immediately after the first two balance tests), and 15 min after baseline (immediately after the final 2 balance tests)
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Blood lactate
Prazo: Blood lactate changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests
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Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
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Blood lactate changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests
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Blood glucose
Prazo: Blood glucose changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
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Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
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Blood glucose changes: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
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Blood pressure
Prazo: Blood pressure change: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
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Objective measure of blood pressure via eletronic blood pressure measuring device
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Blood pressure change: at baseline, 10 min after baseline (immediately after the first two balance tests), 15 min after baseline (immediately after assigned interventions) and 25 min after baseline (immediately after the final two balance tests)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Romain Meeusen, Professor, Vrije Universiteit Brussel
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 143201939780
Plano para dados de participantes individuais (IPD)
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