FlexToBa for People With Multiple Sclerosis
21 de fevereiro de 2017 atualizado por: Edward McAuley, University of Illinois at Urbana-Champaign
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS.
However, there is increasing evidence to support the importance of physical activity in MS.
Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS.
We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS.
This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765).
This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully.
It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS.
Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality.
If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.
Tipo de estudo
Intervencional
Inscrição (Real)
50
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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Illinois
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Urbana, Illinois, Estados Unidos, 61801
- University of Illinois at Urbana-Champaign
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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
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
- aged 50 years and older;
- fluent in English;
- relapse-free in the last 30 days;
- ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
- the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff).
Exclusion Criteria:
- self-reported physical activity on a regular basis within the last six months (2 times or more per week);
- younger than 50 years of age;
- relapse in the last 30 days;
- no regular access to a television;
- no physician-confirmed diagnosis of multiple sclerosis;
- unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M).
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Experimental: FlexToBa physical activity DVD
Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance.
These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels.
Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months.
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Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance.
Exercises will be progressive over the six-months and will highlight modifications for varying levels.
This program will be delivered on 3 DVDs.
Participants will be asked to exercise with the DVD at least three times per week.
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Comparador Ativo: Usual care-Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
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Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
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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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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
Prazo: Baseline and six months
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The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance |
Baseline and six months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Prazo: Baseline and six-months
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Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible; |
Baseline and six-months
|
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Change in assessments of functional fitness assessments in sedentary adults with MS
Prazo: Baseline and six-months
|
Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes; |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Prazo: Baseline and six-months
|
Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength; |
Baseline and six-months
|
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Prazo: Baseline and six-months
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Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility) |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Prazo: Baseline and six-months
|
Measurements will include: Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds; |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Prazo: Baseline and six-months
|
Measurements will include: Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg. |
Baseline and six-months
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Change from baseline to six-months in assessments of reported quality of life in people with MS
Prazo: Baseline and six months
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The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
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Baseline and six months
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Change from baseline to six-months in assessments of reported quality of life in people with MS
Prazo: Baseline and six-months
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The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention.
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Baseline and six-months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Prazo: Baseline and six months
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The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
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Baseline and six months
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Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Prazo: Baseline and six months
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Participants' situation-specific self-confidence for physical activity will be assessed using The Barriers Self-Efficacy Scale, which taps subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation.
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Baseline and six months
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Changes in physical activity relating to specified exercise program in sedentary adults with MS
Prazo: Baseline and six months
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Adherence to exercise program as documented by daily exercise logs.
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Baseline and six months
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Objective changes in physical activity in sedentary adults with MS
Prazo: Baseline and six months
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Objective assessment of physical activity via accelerometry over seven days time.
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Baseline and six months
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Self-reported changes in physical activity in sedentary adults with MS
Prazo: Baseline and six months
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Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
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Baseline and six months
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Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Prazo: Baseline and six-months
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Participants' situation-specific self-confidence for physical activity will be assessed using The Gait Self-Efficacy Scale, which will assess participants' beliefs in their capabilities to negotiate stairs and objects in their path.
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Baseline and six-months
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Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
Prazo: Baseline and six-months
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The Exercise Self-Efficacy Scale will assess participants' beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future.
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Baseline and six-months
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Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Prazo: Baseline and six-months
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Walking Self-Efficacy Scale for Duration will assess participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (up to 40 minutes)of walking at a moderately fast pace.
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Baseline and six-months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Publicações e links úteis
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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
1 de outubro de 2013
Conclusão Primária (Real)
1 de setembro de 2014
Conclusão do estudo (Real)
1 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
18 de outubro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de novembro de 2013
Primeira postagem (Estimativa)
25 de novembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de fevereiro de 2017
Última verificação
1 de fevereiro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IL-0009
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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