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Fit & Active Seniors Trial (FAST)

21 de fevereiro de 2017 atualizado por: Edward McAuley, University of Illinois at Urbana-Champaign

Influence of Fitness on Brain and Cognition II

The investigators propose to test the hypothesis that a six-month intervention of combined fitness and cognitive training in the form of dancing will have a significant positive effect on a variety of executive control and memory processes as well as brain structure and function as compared to a non-aerobic strength and balance control/comparison group. Additionally, these two groups will be compared to walking groups in which one of the walking groups will also be provided with a daily, liquid, milk-based nutritional supplement.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Our previous trial (known as HALT, Healthy Active Lifestyle Trial) suggests that improvements in aerobic fitness have beneficial effects on cognitive function that are rather specific. That is, improvements in aerobic fitness appear to result in improvements in executive control processes such as scheduling, planning, coordination, inhibition, and working memory - some of the very cognitive abilities most affected during aging. Indeed, executive control processes and the prefrontal and frontal regions which support them have shown substantial and disproportionate age-related declines. The main hypothesis that the investigators test in the present project is that such deficits may be particularly benefited by improvements in aerobic fitness combined with cognitive training in the form of dance. Additionally, we will compare the outcomes of these interventions with an aerobic condition (walking) group and an aerobic condition (walking) group that also is provided with a daily nutritional supplement (walking + nutrition). The investigators will examine the relationship between aerobic fitness, physical activity, cognitive status, and brain function with this six-month aerobic training intervention study. The investigators will collect psychosocial data and functional fitness data to assess other relevant changes in psychological and physical function brought about by exercise training. Healthy, non-active older adults (60 to 79 years of age) will be recruited from the local community. Half One quarter of the older adults will be randomly assigned to an aerobic/cognitive combination group (dance), one quarter will be while the remaining half of the older adults will be randomly assigned to a non-aerobic control group (stretching, strengthening, and stability), one quarter will be assigned to the walking group, and one quarter will be assigned to the walking + nutrition group. The exercise interventions will be conducted by trained exercise staff. The participants will be assessed before and after the intervention (6 months). Assessments will include (a) cardiorespiratory testing, (b) physical activity monitoring (c) performance on neurocognitive tests of executive and non-executive function (d) measures of brain activation (fMRI) during cognitive tasks in a 3.0 tesla MRI system (e) a battery of psychosocial questionnaires (f) functional performance measures and (g) a mock street walking task.

Tipo de estudo

Intervencional

Inscrição (Real)

247

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

  • Estados Unidos
    • Illinois
      • Urbana, Illinois, Estados Unidos, 61801
        • University of Illinois

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

60 anos a 79 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 60-79 years of age
  • Low-active: zero to two days of physical activity (> 30 minutes per day) per week in previous six months.
  • Personal physician's examination and/or consent to participate in testing and exercise intervention
  • Successful completion of graded exercise test without evidence of cardiac abnormalities or responses which are likely to be exacerbated by exercise. This decision will be made by the attending cardiologist.
  • Adequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire
  • Corrected (near and far) acuity of 20/40 or better in both eyes and no diagnosis of color-blindedness
  • Initial depression score on GDS-15 (Geriatric Depression Scale) below clinical level (> 10)
  • No presence of implanted devices or metallic bodies above the waist
  • No history of brain surgery that involved removal of brain tissue
  • Right-handed
  • No history of stroke or Transient ischemic attack(TIA)
  • Intention to remain in the local area for the duration of the intervention or testing period
  • English fluency

Exclusion Criteria:

  • Below 60 years of age or above 80 years of age at beginning of intervention
  • Self-reported regular physical activity of more than 2 times per week in last six months
  • Non-consent of physician
  • Evidence of abnormal cardiac responses or conditions during graded exercise testing
  • Inadequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire (<20)
  • Uncorrectable (near and far) acuity of greater than 20/40 in either eye and/or color-blindness
  • Depression score on GDS-15 indicative of clinical depression (≤ 10)
  • Presence of any implanted devices above the waist i.e. cardiac pacemaker or auto-defibrillators; neural pacemaker; aneurysm clips in the Central Nervous System(CNS); cochlear implant; metallic bodies in the eye or CNS; any form of wires or metal devices that may concentrate radiofrequency fields
  • History of brain surgery that involved removal of brain tissue
  • Left-handed
  • History of Stroke or TIA
  • Intent to move or be away from the area for an extended period of time (i.e. > 3 weeks) during the intervention or testing period
  • Inability to communicate effectively in English

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dance
Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
Comportamental: Dance Group
Participants will be instructed and learn various forms of dance (i.e. English country, folk, ballroom) and will be led by trained dance instructors and exercise specialists. Participants will for one-hour sessions and meet three times per week for six months.
Outros nomes:
  • Fit & Active Seniors Trial
Comparador Ativo: Strengthening, Stability, Stretching
Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
Comportamental: Strength, Stretching, Stability
Exercises focusing on strength, flexibility and balance will be performed at one-hour sessions held three times per week for six months. Classes are led by trained exercise specialists.
Outros nomes:
  • Fit & Active Seniors Trial
Experimental: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
Comportamental: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
Experimental: Walking + Nutritional Supplement
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. These participants will also be provided with a daily nutritionally balanced liquid, milk-based formula.
Comportamental: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
Comportamental: Walking + Nutrition
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists. These participants will also be provided with a daily nutritionally balanced liquid, milk-based supplement formula.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline to month six in brain structure and function
Prazo: Baseline and six months
Participants will undergo a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six. They will also undergo an fMRI during which images of brain structure and function (completing tasks during image collection) will be compared from baseline to month six.
Baseline and six months
Change from baseline to month six in cardiorespiratory fitness
Prazo: Baseline and six months
We will conduct graded maximal exercise treadmill test measuring peak oxygen consumption at baseline and six months.
Baseline and six months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline to month six: Quality of life
Prazo: Baseline and six months
We will assess multiple indicators of Quality of Life such as: depression; physical and mental health status; satisfaction with life; etc.
Baseline and six months
Change from baseline to month six: Self-efficacy
Prazo: Baseline, three weeks and six months
We will examine the extent to which self-efficacy (e.g. barriers, adherence, function) changes as a function of participation in regular group physical activity training.
Baseline, three weeks and six months
Program adherence over six month intervention
Prazo: Six months
We will monitor attendance during the six-month intervention(program meets three days per week).
Six months
Change from baseline to month six: Physical function
Prazo: Baseline and six months
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Baseline and six months
Change from baseline to month six: Psychosocial Outcomes
Prazo: Baseline and six months
We will assess changes in psychosocial function (e.g. self-esteem; social support; anxiety) by written questionnaires.
Baseline and six months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Illinois at Urbana-Champaign

Investigadores

  • Investigador principal: Arthur F Kramer, PhD, University of Illinois at Chicago

Publicações e links úteis

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Publicações Gerais

Links úteis

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 agosto de 2011

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)

1 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de novembro de 2011

Primeira postagem (Estimativa)

16 de novembro de 2011

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

Outros números de identificação do estudo

  • R37AG025667 (Concessão/Contrato do NIH dos EUA)
  • 392 (Center for Nutrition, Learning and Memory UIUC)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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