Preventive Program in Multiple Sclerosis
27 de janeiro de 2021 atualizado por: Kamila Řasová
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life.
The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training.
The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart.
Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).
Tipo de estudo
Intervencional
Inscrição (Real)
17
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
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Praha, Tcheca, 128 00
- Kamila Řasová
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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
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- definite MS
- stable clinical status in the preceding 3 months
- imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab)
- Expanded Disability Status Scale (EDSS)≤6
- predominant motor impartment
- six months or more without any physiotherapy
- ability to undergo ambulatory physiotherapy
Exclusion Criteria:
- other neurological disease or conditions disabling movement
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: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise
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Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes.
Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.
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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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Questionnaires - The Fatigue scale for motor and cognitive functions
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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FSMC - is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - The Satisfaction With Life Scale
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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The scale measures the current level of satisfaction with one's own life.
Investigators express the extent to which they agree or disagree with the five statements.
The rating scale contains 7 points (1- "strongly disagree" and 7 - "strongly agree").
The maximum number of points on the scale is 35 (maximum satisfaction with your life) and the minimum number of points is 5 (dissatisfaction with your life).
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - Multiple Sclerosis Acceptance Questionnaire
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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This questionnaire consists of 20 statements that relate to the lives of patients with MS.
The rating scale has seven points (1- "never pays" to 7 - "always pays").
The minimum value is 20 (minimum adaptation to the diagnosis of MS for a large limitation of the normal life of MS) and the maximum value is 140 points (maximum adaptation to the diagnosis of MS - without the limitation of the normal life of MS) .
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - Beck Depression Inventory Score
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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questionnaire is divided into thirteen categories and patients select a statement in each category which best fits their current feelings on the scale ranged from 0 (the best feelings) to 3 (the worst feelings).
The maximum value of the total scale is 39 and shows the worst feeling of the person.
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change after six months of the program and after next six moths without therapy is being assessed
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ventilation capacity
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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Forced vital capacity = FVC [ l ]
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change after six months of the program and after next six moths without therapy is being assessed
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Metabolic utilization
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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maximal muscle performance = Rmax [ Watt kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Maximal oxygen uptake
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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VO2 kg-1 [ VO2max.kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Maximal oxygen pulse
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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VO2 HR-1 kg-1 [ VO2max.TF-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Relative ventilation
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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[ VEmax.kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Cortisol
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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levels of cortisol [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Cortizone
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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levels of cortisone[ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Dehydroepiandrosterone (DHEA)
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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levels of DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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levels of 7β-OH-DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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7-oxo dehydroepiandrosterone (7-oxo-DHEA )
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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levels of 7-oxo-DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Questionnaires - Modified Fatigue Impact Scale
Prazo: change after six months of the program and after next six moths without therapy is being assessed
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This scale consists of 21 statements that describe how often fatigue has affected a person during last four weeks.
Each statement is ranged from 0 (never) to 4 (almost, always).
The maximum value of the scale is 84.
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change after six months of the program and after next six moths without therapy is being assessed
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
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)
1 de outubro de 2017
Conclusão Primária (Real)
1 de outubro de 2019
Conclusão do estudo (Real)
1 de outubro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
20 de novembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de dezembro de 2020
Primeira postagem (Real)
14 de dezembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de fevereiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EK-VP/25/0/2014
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