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- Ensaio Clínico NCT04881422
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.
The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Laura LM Mendozzi, MD
- Número de telefone: +39 02 40308571
- E-mail: lmendozzi@dongnocchi.it
Locais de estudo
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Milan, Itália
- Recrutamento
- Irccs Fondazione Don Carlo Gnocchi
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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:
- aged 18 to 70 years
- EDSS ranging from 1 to 7.5.
- pwMS with who are on a western diet
- stabilized medical therapy and clinical conditions
- pwMS with a motor control of upper limbs sufficient to maneuver a tiller
Exclusion Criteria:
- Heavy smoking, alcohol and drugs abuse
- severe cognitive impairment
- dysphagia and/or comorbidities requiring protected environments and specific medical assistance
- blindness and severe visual disturbances (included severe nystagmus)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Experimental group
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
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The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course).
Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
FS-36 Health Related Quality of Life (HRQoL)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure Health-Related Quality of Life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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The Fatigue Severity Scale (FSS)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure the fatigue
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Food frequency questionnaire (FFQ)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to evaluate usual frequency of foods and beverages
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
MSIS29- Multiple Sclerosis Impact Scale
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the impact of MS on day-to-day life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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MOS Sleep Scale (MOSS)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the quality and the quantity of sleep
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Restless Legs Scale (RLS)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the restless legs syndrome
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Six minute walking test (6MWT)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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An exercise test used to assess aerobic capacity and endurance
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Hospital Anxiety and Depression Scale (HADS)
Prazo: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A self-assessment scale for detecting states of depression and anxiety
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- 07_23/05/2018
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