Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.
The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.
Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Saint Etienne, França, 42055
- CHU 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:
- Patient lived in t Loire (42) or Haute-Loire (43)
- Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
- French writing and speaking
- Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
- Signature of informed consent
Exclusion Criteria:
- Cardiac or respiratory diseases that contraindicate the practice of physical activity
- Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
- Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: pacientes com fibromialgia com programa de atividade física
Duas sessões semanais de exercícios no hospital universitário de St-Etienne por 1 mês, depois revezamento externo em uma associação esportiva ou clube certificado "Sports Health" no Loire (42) ou Haute-Loire (43) por 2 meses.
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Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.
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Outro: pacientes com fibromialgia com atividade física em casa
Conselhos e recomendações de atividade física em casa (= prática clínica atual, de 1 a 3 sessões por semana em autonomia).
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Conselhos e recomendações de atividade física em casa (= prática clínica atual, de 1 a 3 sessões por semana em autonomia).
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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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Assessment of the impact of a 3-month program
Prazo: at 3 months
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Health status assessed by the PGIC = Patient Global Impression of Change.
interpretation : 0= no change, 7= clear improvement, 5= better).
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at 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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fatigue
Prazo: at 3 months
|
assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5 |
at 3 months
|
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Quality of sleep
Prazo: at 3 months
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assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties. |
at 3 months
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Anxiety and Depression
Prazo: at 3 months
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assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode.
An overall score of 13 corresponds to adjustment disorders and minor depression.
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at 3 months
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pain catastrophizing
Prazo: at 3 months
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assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are.
From 0= not at all to 4 = all the time
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at 3 months
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pain evaluation
Prazo: at 3 months
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assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
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at 3 months
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muscle power
Prazo: at 3 months
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evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
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at 3 months
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muscular endurance
Prazo: at 3 months
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evaluated by dynamometry on a stress platform (arms and legs).
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at 3 months
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gas exchange measurement
Prazo: at 3 months
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evaluated during a stress test
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at 3 months
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quantification of physical activity in meter-h/week
Prazo: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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sedentary times in hours/day
Prazo: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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daily energy expenditure
Prazo: at 3 months
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evaluated by actimetry
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at 3 months
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time of physical activity
Prazo: at 3 months
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evaluated by actimetry
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at 3 months
|
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physical inactivity
Prazo: at 3 months
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evaluated by actimetry
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at 3 months
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patient adherence
Prazo: at 3, 6 and 12 months
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number of sessions performed
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at 3, 6 and 12 months
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Direct medical costs
Prazo: at 3, 6 and 12 months
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consultations, examinations, hospitalizations in euros
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at 3, 6 and 12 months
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Direct non-medical costs
Prazo: at 3, 6 and 12 months
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transport
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at 3, 6 and 12 months
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Cost of lost productivity
Prazo: at 3, 6 and 12 months
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time not worked
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at 3, 6 and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David HUPIN, MD, Chu de Saint Etienne
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 18CH051
- 2018-A01597-48 (Outro identificador: ANSM)
Plano para dados de participantes individuais (IPD)
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