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Active Class Space Metabolic Benefits Study (ACS)

12 de julho de 2016 atualizado por: Rebecca Hasson, University of Michigan
ACS examined the potential influence of intermittent physical activity breaks of various intensities (control, light, moderate, vigorous) on measures of immediate mental performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon previous work to hypothesize that higher-intensity intermittent physical activity breaks throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise physical activity levels, while reducing hunger and post-exercise food intake.

Visão geral do estudo

Descrição detalhada

Background: A range of metabolic, behavioral, mental and physical health benefits of regular physical activity have been documented in adults and children in the long-term. Yet, relatively little is known about how children's usual daily physical activity patterns (i.e. small bursts throughout the day) affect acute (immediately post-activity) and short-term (72 hours post-activity) metabolic and psychosocial outcomes. Additionally, little is known how this specific pattern of physical activity affects subsequent physical activity levels (i.e. compensatory behavior) and subsequent dietary intake, over the short-term- information critical to designing effective interventions involving the physical environment of the school classroom. Overall Goal: Active Class Space (ACS) will examine the potential influence of intermittent physical activity breaks of various intensities (control, light, moderate, vigorous) on measures of immediate mental performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon previous work to hypothesize that higher-intensity intermittent physical activity breaks throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise physical activity levels, while reducing hunger and post-exercise food intake. Specific Aims: (1) To determine the effects of intermittent physical activity breaks of varying intensities on immediate mental performance, hunger and satiety; (2) To determine the effects of intermittent activity breaks of varying intensities on ratings of perceived exertion (RPE), perceived exercise enjoyment, in-task mood, post-exercise food intake and post-exercise physical activity levels; and (3) To examine gender differences in the preceding variables in response to low-, moderate, and high-intensity intermittent physical activity. Design: Eighteen healthy males and twenty-one healthy females between the ages of 7-11 years completed completed four experimental conditions in random order: (1) 8 hours of sitting interrupted with 2--minute, light--intensity activity breaks performed at 25% of heart rate reserve (HRR) every 18 minutes; (2) 8 hours of sitting interrupted with 2--minute, moderate--intensity activity breaks (50% HRR); (3) 8 hours of sitting interrupted with 2--minute, high--intensity activity breaks (75% HRR); and (4) 8 hours of sitting interrupted with 2 minutes of sedentary screen time. Standardized meals will be provided during each experimental condition. Dietary intake and physical activity levels were monitored for the remainder of the experimental day and over the subsequent three days for each condition. Dependent Variables: Major outcome variables include: Energy expenditure measured by indirect calorimetry and heart rate; dietary intake measured using a 3-day dietary record; physical activity measured by accelerometry; immediate mental performance assessed using a 90-sec mathematical computation test; hunger and satiety assessed using a visual analog scale; RPE assessed using the Borg scale; perceived exercise enjoyment assessed using the physical activity enjoyment scale (PACES); in-task mood assessed using the Feeling Scale (FS) and Subjective Exercise Experiences Scale (SEES). Data Analysis: A linear mixed model will be fitted for each outcome variable with effects for condition, sex, BMI, and baseline physical activity level. A Bonferroni correction will be used to adjust for multiple comparisons in post hoc tests following the mixed-effect model. A similar linear mixed-model for raw levels of each outcome variable over time will also be fitted to assess temporal differences between conditions. This model will include effects for condition, time, time-by-condition interaction, sex, BMI, and baseline physical activity levels. Significance: ACS will shed new light on the short-term metabolic, behavioral, mental and physical health benefits of intermittent physical activity breaks in children. The results from this study will inform the design of behavioral and environmental interventions to promote physical activity and cognitive development in pediatric populations.

Tipo de estudo

Intervencional

Inscrição (Real)

39

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

    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Childhood Disparities Research Laboratory

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

7 anos a 11 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Children ages 7-11 years old from the greater Ann Arbor and Ypsilanti areas were recruited to participate in this study.

Exclusion Criteria:

  • Participants were excluded based on the following criteria: (1) were taking medications or were diagnosed with diseases that could influence exercise ability or cognitive function and (2) were previously diagnosed with any major illness/health condition since birth.

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: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Falso: Sedentary Condition
Forty minutes of screen time. Standardized meals provided.
The sedentary condition consisted of 8 hours of sitting interrupted with 2-minutes of screen time every 18 minutes. Standardized meals were provided.
Comparador Ativo: Light-Intensity Condition
Forty minutes of light-intensity activity. Standardized meals provided.
The light-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, light--intensity activity breaks performed at 25% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
Comparador Ativo: Moderate-Intensity Condition
Forty minutes of moderate-intensity activity. Standardized meals provided.
The moderate-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, moderate-intensity activity breaks performed at 50% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
Comparador Ativo: High-Intensity Condition
Forty minutes of high-intensity activity. Standardized meals provided.
The high-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, vigorous-intensity activity breaks performed at 75% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Physical activity energy expenditure
Prazo: 4 days
Physical activity energy expenditure throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Energy expenditure was calculated from accelerometer data.
4 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
40-item immediate mental performance math test
Prazo: 1 day
Number of math questions answered correctly within 90 seconds in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were marked as number correct out of 40.
1 day
Dietary intake
Prazo: 4 days
Standardized meals were provided in the morning, midday and evening and 3-day dietary records were collected three days post-condition day. Total daily dietary intake was calculated from food consumed in the lab and at home.
4 days
Physical activity minutes
Prazo: 4 days
Physical activity minutes throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Minutes participating in physical activity was calculated using accelerometer data.
4 days
4-item hunger and satiety visual analog scale
Prazo: 1 day
Self reported hunger and satiety in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were calculated from a visual analog scale ranging from 0-100 (0= hungry; 0=full), yielding a total between 0- 400
1 day
Single-item ratings of perceived exertion
Prazo: 1 day
Perceived exertion during 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored 6-20 (6 = light exertion; 20 maximal exertion).
1 day
Single-item feeling scale
Prazo: 1 day
Participants self-reported how they felt during each 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored -5 to +5 (-5 = very bad; +5 = very good).
1 day
16-item exercise enjoyment measure
Prazo: 1 day
Self-reported mood in the morning (800hr), midday (1200hr) and afternoon (1600hr). The scale is a combination of 16 positive and negative statements. The responses were scored on a 5-point Likert like scale (1= disagree a lot, 5 = agree a lot). Seven of the 16 statements were reverse scored.
1 day
12-item psychological mood measure
Prazo: 1 day
Self-reported mood at midday (1200hr) and afternoon (1600hr). A 3 dimensional, 12-item scale designed to measure changes in 3 categories; positive well-being (e.g., i feel terrific), psychological distress (e.g., i feel miserable), and fatigue (e.g., i feel exhausted). For each item participants will be asked to indicate how strongly they are experiencing the feeling state at that time. Items will be scored on a 7-point Likert scale (1 = "not at all," 7 = "very much so"). Each subscale ranges from 4 to 28 with higher scores representing greater fatigue, positive well-being or psychological distress.
1 day

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Rebecca E Hasson, PhD, University of Michigan

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 junho de 2014

Conclusão Primária (Real)

1 de agosto de 2015

Conclusão do estudo (Real)

1 de agosto de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de julho de 2016

Primeira postagem (Estimativa)

13 de julho de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

13 de julho de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de julho de 2016

Última verificação

1 de julho de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • HUM00084540

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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