- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00922857
Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure (INSPIRE)
The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance, this relates to 50,000 patients in France, life expectancy is very limited, and quality of life is poor.
CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are not yet established. Recently, a chronic inflammatory condition has been quoted as a putative cause. This chronic inflammation would involve the molecular mechanisms leading to poor regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could explain a lack of protein synthesis.
It is now well established that respiratory rehabilitation, including a program of exercise reconditioning, increases tolerance to exercise and improve the quality of life. Besides the classical type of endurance exercises stimulating the cardio-respiratory system, it is suggested to add resistance exercises. Several studies have reported the benefit of this strategy but the link with intracellular molecular pathways has not been described; moreover, it is unknown whether the existence of an initial muscular atrophy influences the gain in muscle strength/mass.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
We therefore propose to explore the effect of a rehabilitation program including endurance and resistance exercises on muscle biopsies.
The present study should help to know the molecular pathways implicated in muscle atrophy in CRF patients and to assess their evolution with rehabilitation. This could lead to individualized recommendation for exercise program according to the muscle mass of the patients.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Saint-etienne, França, 42055
- CHU de Saint-Etienne
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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:
- Prescription of an exercise training program as part of a respiratory rehabilitation
- Existence of an obstructive ventilatory deficit
- Signature of written consent
Exclusion Criteria:
- Exacerbation of COPD
- Patient with a long-term oxygen therapy
- Active smoker
- Lower limb locomotor limitation preventing to achieve the full respiratory rehabilitation program
- Lower limbs arteritis
- Myocardial infarction or pulmonary embolism of less than 3 months
- Long term anticoagulant
- Type 1 diabetes
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Respiratory rehabilitation
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The training begins 5 days after the initial assessment.
It consists of 3 weekly sessions for 8 consecutive weeks, including the following activities interspersed with periods of rest, according to the needs of patients
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Gain in exercise tolerance (relative variation of the 6 min walking distance and maximal exercise capacity on bicycle (peak VO2) combined with activation of the pathway for muscle protein synthesis
Prazo: before and at the outcome of the reconditioning program in the effort
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before and at the outcome of the reconditioning program in the effort
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Quality of life assessed by questionnaire
Prazo: before and at the outcome of the reconditioning program in the effort
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before and at the outcome of the reconditioning program in the effort
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frédéric COSTES, MD PhD, CHU de Saint-Etienne
Publicações e links úteis
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0408079
- 2005/0023 (Outro identificador: DGS)
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