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Cardiovascular Risk in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time

2016年9月2日 更新者:Eduardo Ferriolli、University of Sao Paulo

Blood Glucose, Insulin Response and Inflammatory Markers in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time

In adults, the sedentary behavior was related to cardiovascular risk markers, regardless of the level of physical activity (PA). However, the interruption of prolonged sedentary time has shown positive results even when performed in breaks of low intensity and short duration of activity. The aim of this study is to analyze the influence of a sedentary uninterrupted period, as well as different forms of breaks in sedentary time for the glycemic, insulin and inflammatory markers responses in older adults. This is a controlled clinical trial to be conducted in older (≥ 65 years) and sedentary (<150 min / week of moderate to vigorous physical activity) people. Those with BMI ≥ to 35.00 kg /m2; diabetic, on medication for glycemic control, or with absolute or relative contraindications to PA practice will not be included . Participants will undergo four phases of intervention separated by an interval of 7 days: (1) Prolonged Sitting Time(PST), in which older people will stay for 5 hours seated; (2) Prolonged sitting with PA of light intensity and short duration (LiSd), time sitting is interrupted for PA bouts of 50-60% of the Heart Rate (HR)max; (3) Prolonged sitting with PA of moderate intensity and short duration (MiSd), time sitting will be interrupted for PA bouts of 65-75% predicted HR max; (4) Prolonged sitting with PA of moderate intensity and long duration (MiLd,) time sitting will be interrupted with PA bouts of 65-75% of HRmax. PA bouts will be performed by walking into a hallway every 20 minutes of sitting time and will last 2 minutes, except in MiLd phase (10 minute breaks every 75 minutes). To evaluate the effects of different PA interruptions in plasma glucose, serum insulin and inflammatory markers, blood samples will be collected serially (-30min, Baseline and 30min, 1h, 2h, 3h, 4h and 5h after a standardized meal. It is expect that interruption of sedentary time, even with breaks of short duration and light intensity can bring benefits to cardiovascular risk markers even in the elderly.

研究概览

研究类型

介入性

注册 (预期的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • São Paulo
      • Ribeirão Preto、São Paulo、巴西、14048-900
        • 招聘中
        • Clinics Hospital of the Ribeirao Preto Medical School

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Sedentary older women according World Health Organization, defined as not performing moderate to vigorous physical activity and vigorous for 150 min / week for at least 3 months;
  • BMI <to 35.00 kg / m2;
  • Sign the Informed Consent.

Exclusion Criteria:

  • Previous diagnosis of Diabetes Mellitus;
  • Use of any medication for glycemic control;
  • Orthopedic problems that impair walking or use of orthoses for walking.
  • Relative or absolute contraindications to perform physical activity.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Prolonged Sitting Time (PST)
Uninterrupted sitting time of 5 hours
Volunteers will be continuously sitting on a chair for 5 hours and should move the least possible. If the participant needs to stand from the chair, the stage will be invalidated.
实验性的:PST+Light intensity Short bouts PA
Sitting prolonged interrupted with breaks of 2 minutes of light physical activity
Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of low intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 50-60% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes) of light intensity physical activity.
实验性的:PST+Moderate intensity Short bouts PA
Sitting prolonged interrupted with breaks of 2 minutes of moderate physical activity
Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of moderate intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes)of moderate intensity physical activity.
实验性的:PST+Moderate intensity Long bouts PA
Sitting prolonged interrupted with breaks of 10 minutes of moderate physical activity
Volunteers will have their time sitting interrupted every 75 minutes for 10 minutes of physical activity of moderate intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (3 bouts of 10 minutes) of moderate intensity physical activity.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in blood glucose area under curve during 5 hours in four different phases of intervention
大体时间:4 weeks
Assessed by serial blood sampling.The first blood sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein. The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal). The results will be expressed in mg.dl.
4 weeks
Change in insulin area under curve during 5 hours in four different phases of intervention
大体时间:4 weeks
Assessed by serial blood sampling. The first blood sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein. The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal).The results will be expressed in µIU/ml.
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Assessment of physical performance
大体时间:1 day
The physical performance will be evaluated by the Short Physical Performance Battery test.
1 day
Assessment of handgrip strength
大体时间:1 day
Measure of handgrip strength with a manual dynamometer (Saehan)
1 day
Assessment of muscle strength of knee extensors
大体时间:1 day
Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)
1 day
Physical Activity behaviour
大体时间:7 days
use of a tri-axial accelerometer to measure profile of spontaneous physical activity
7 days
Change in Inflammatory Cytokines area under curve during 5 hours in four different phases of intervention
大体时间:4 weeks
Assessed by serial blood sampling. The first sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein. The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal).
4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Eduardo Ferriolli, PhD、USao Paulo

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年8月1日

初级完成 (预期的)

2016年12月1日

研究完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2016年7月26日

首先提交符合 QC 标准的

2016年9月2日

首次发布 (估计)

2016年9月9日

研究记录更新

最后更新发布 (估计)

2016年9月9日

上次提交的符合 QC 标准的更新

2016年9月2日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1563/2015

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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