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Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV (ACT PHY HIV)

23 de julho de 2018 atualizado por: Centre Hospitalier Universitaire de Nice

Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life . This would include physical deconditioning, a reduction in motor skills . Numerous studies show that physical activity brings benefits for the quality of life of PHAs . However, due to the predominantly reported fatigue, many PHAs are not physically active enough in relation to these recommendations. While it is recognized that fatigue is predominant in PHAs, this complaint has mainly been subjectively quantified and has rarely been physically objectified a better understanding of the relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue.

OBJECTIVES This project, based on an integrative (eg, neurophysiological and psychological) approach to fatigue, aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue, perceived fatigue, Physical activity of patients.

The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs.

The secondary objective will be to examine the relationship between neuromuscular fatigue, level of physical activity and perceived physical fatigue of PHAs.

CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment; The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups

  • Principal evaluation criterion: Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve.
  • Secondary evaluation criteria: the investigation of the perceived fatigue will be done by a valid psychometric questionnaire.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

RATIONAL Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life . This would include physical deconditioning, a reduction in motor skills . Numerous studies show that physical activity brings benefits for the quality of life of PHAs. However, due to the predominantly reported fatigue, many PHAs are not physically active enough in relation to these recommendations. While it is recognized that fatigue is predominant in PHAs, this complaint has mainly been subjectively quantified and has rarely been physically objectified. , a better understanding of the relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue.

OBJECTIVES OF THE STUDY This project, based on an integrative (eg, neurophysiological and psychological) approach to fatigue, aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue, perceived fatigue, Physical activity of patients.

The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs.

The secondary objective will be to examine the relationship between neuromuscular fatigue, level of physical activity and perceived physical fatigue of PHAs.

CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment; The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups: (a) a group of patients considered as physically active (SAP> 22) and (b) a group of patients considered as Physically inactive (SAP <15). Confirmed by blood diagnosis. Those who have recently stopped their antiretroviral treatment and / or their medical follow-up and who have a progressive recovery of their infection and those affected by other health conditions marked by fatigue will be excluded.

  • Principal evaluation criterion: Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve.
  • Secondary evaluation criteria: the investigation of the perceived fatigue will be done by a valid psychometric questionnaire.

Tipo de estudo

Intervencional

Inscrição (Real)

15

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

      • Nice, França, 06200
        • CHU de Nice

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

40 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • HIV patient - PLHIV (person living with HIV)
  • Patient aged between 40 and 60
  • patient attended the Nice University Hospital

Exclusion Criteria:

  • Patient refusing to sign informed consent
  • Subjects with motor disabilities;
  • Subjects incapable of answering questionnaires independently;
  • Subjects with anosognosia;
  • Subjects with contraindications to physical practice;
  • Persons co-infected with HCV or HBV
  • People with associated fatigue-associated comorbidity (renal disease, cancer, multiple sclerosis (Harmon et al., 2008)
  • Women who have been pregnant or have given birth in the previous twelve months
  • Subjects with contraindications to magnetic stimulation (hearing disorders or carriers of metallic material.
  • Subjects under tutelage, under curatorship or under safeguard of justice;
  • Persons deprived of their liberty (administrative or judicial).
  • Persons hospitalized without consent
  • Persons admitted to a health or social institution for purposes other than research
  • Persons of legal age who are the object of a legal protection measure or who are unable to express their consent

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: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Patients considered physically active
Measures of strength and determination of neuromuscular fatigue
Neuromuscular tests
Comparador Ativo: Patients considered physically inactive
Measures of strength and determination of neuromuscular fatigue
Neuromuscular tests

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity
Prazo: through study completion, 1 year after the start
through study completion, 1 year after the start

Colaboradores e Investigadores

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

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 (Real)

19 de abril de 2017

Conclusão Primária (Real)

19 de abril de 2018

Conclusão do estudo (Real)

12 de junho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

30 de dezembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de abril de 2017

Primeira postagem (Real)

24 de abril de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2018

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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 Soropositividade para HIV

Ensaios clínicos em Neuromuscular tests

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