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Exercise and Cognition Trials (EXACT)

2017年8月15日 更新者:Johns Hopkins University

Human Performance: Role of Acute Exercise in Enhancing Cognitive Function

The purpose of this study is to determine whether an acute bout of exercise may temporarily enhance cognitive function (such as memory or attention span) by measuring behavioral performance on cognitive tests, as well as expression of hormones in circulation associated with brain plasticity and stress.

研究概览

地位

完全的

详细说明

This is a randomized experiment consisting of three visits for each participant. Participants are determined to be eligible beforehand during a phone screening, in which the various study inclusions and exclusions are determined and the Physical Activity Readiness Questionnaire for Everyone 2015 (PARQ) is administered.

In the first visit, various anthropometric data are collected from participants, such as height, weight, and waist and hip circumference. The participants' blood pressure is also checked for hypertension. The participants are given Dual Energy X-Ray Absorptiometry (DEXA) scans to determine total body composition (bone, fat, and fat-free mass) If the participant is female, a urine analysis to determine pregnancy is required during the visit before the DEXA to ensure safety. Participants are given the Rapid Assessment of Physical Activity (RAPA) questionnaire to assess habitual activity levels. The participants' muscle strength is also measured using the Biodex System 3, an isokinetic dynamometer. The participants then undergo a maximal stress test on a treadmill integrated with a Cardinal Health Metabolic/ECG cart using a modified Balke protocol, beginning at 3 mph, 0% grade, and increasing 2.5% grade every 3 minutes. The ECG component of the metabolic cart will be used for continuous heart rate monitoring as part of the fitness assessment. Cardiorespiratory parameters (VO2, ventilation, respiratory rate) will also be measured throughout the test. Blood pressure is measured during the last 30 seconds of each exercise stage and the rating of perceived exertion (RPE) using the Borg 6 to 20 scale is obtained during each stage. Subjects are urged to give a maximal effort and are pushed until volitional fatigue.

In the second visit, participants are first given a series of cognitive tests designed to quantify such cognitive faculties as visual short-term memory, selective attention, processing speed, and verbal fluency. These tests consist of seeing simple images on a computer screen, such as a series of colored shapes, and responding using a keypad. A blood sample is also collected from the participants to serve as a baseline. The subject is then randomized to one of three groups: the first group rests for 30 minutes; the second group walks on the treadmill at a mild intensity, defined as maintaining 60% of the heart rate observed during the max VO2 from the first visit; the last group walks on the treadmill at a hard intensity, defined as maintaining 80% of the heart rate observed during the max VO2 from the first visit. The subjects then undergo a second blood draw after cooling down, followed immediately by another round of the same cognitive tests. An hour after finishing the exercise intervention, the same procedure of blood draw followed by cognitive tests is repeated, and an hour after that it is repeated again.

The third visit must be about 24 hours after the previous visit. Participants have blood drawn and one final round of cognitive tests.

研究类型

介入性

注册 (实际的)

60

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

    • Maryland
      • Baltimore、Maryland、美国、21224
        • Johns Hopkins Bayview Medical Center

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

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Body mass index (BMI) of between 18.5 and 35 kg/m2
  • Normal or corrected-to-normal vision
  • No contraindications to participation in moderate to hard intensity physical activity

Exclusion Criteria:

  • Self-report of alcohol or substance abuse in the past year or current treatment
  • Women who are pregnant or nursing
  • BMI of < 18.5 or > 35 kg/m2
  • Diabetes mellitus. Subjects will be excluded for diabetes even if controlled by medications
  • Cigarette smoking in the previous 12 weeks
  • Elevated blood pressure (BP) defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg
  • Self-report of cardiovascular disease, cancer, renal disease, and other serious conditions that could be exacerbated by moderate intensity 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

  • 主要用途:基础科学
  • 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
无干预:Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
实验性的:Mild Exercise
Participants randomly assigned to this arm are made to maintain a heart rate equivalent to 60% of the heart rate observed when VO2 max was achieved in the maximal stress test from the first visit.
Participants randomized to an exercise condition will perform treadmill exercise for 30 minutes. Participants will self-select a comfortable walking speed. The treadmill grade will be adjusted to elicit and maintain the target heart rate.
实验性的:Hard Exercise
Participants randomly assigned to this arm are made to maintain a heart rate equivalent to 80% of the heart rate observed when VO2 max was achieved in the maximal stress test from the first visit.
Participants randomized to an exercise condition will perform treadmill exercise for 30 minutes. Participants will self-select a comfortable walking speed. The treadmill grade will be adjusted to elicit and maintain the target heart rate.

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
visual short-term memory questionnaire
大体时间:baseline
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
baseline
visual short-term memory questionnaire
大体时间:up to 5 minutes post intervention
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
up to 5 minutes post intervention
visual short-term memory questionnaire
大体时间:1 hour after intervention
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
1 hour after intervention
visual short-term memory questionnaire
大体时间:2 hours after intervention
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
2 hours after intervention
visual short-term memory questionnaire
大体时间:24 hours after baseline
participants are shown sets of colored squares briefly and must pick out the square that changed color after a delay, scored on accuracy (0-100%)
24 hours after baseline
visual long-term memory questionnaire
大体时间:24 hours after baseline
participants encode images in a cover task at baseline, scored on accuracy (0-100%)
24 hours after baseline
verbal fluency
大体时间:baseline
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
baseline
verbal fluency
大体时间:up to 5 minutes post intervention
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
up to 5 minutes post intervention
verbal fluency
大体时间:1 hour after intervention
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
1 hour after intervention
verbal fluency
大体时间:2 hours after intervention
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
2 hours after intervention
verbal fluency
大体时间:24 hours after baseline
participants are asked to name as many words as they can that begin with a certain letter within 1 minute, scored on number of appropriate words
24 hours after baseline
cortisol in circulation
大体时间:baseline
in nanograms per milliliter (ng/ml)
baseline
cortisol in circulation
大体时间:up to 5 minutes post intervention
in nanograms per milliliter (ng/ml)
up to 5 minutes post intervention
cortisol in circulation
大体时间:1 hour after intervention
in nanograms per milliliter (ng/ml)
1 hour after intervention
cortisol in circulation
大体时间:2 hours after intervention
in nanograms per milliliter (ng/ml)
2 hours after intervention
cortisol in circulation
大体时间:24 hours after baseline
in nanograms per milliliter (ng/ml)
24 hours after baseline
igf-1 in circulation
大体时间:baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
baseline
igf-1 in circulation
大体时间:up to 5 minutes post intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
up to 5 minutes post intervention
igf-1 in circulation
大体时间:1 hour after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
1 hour after intervention
igf-1 in circulation
大体时间:2 hours after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
2 hours after intervention
igf-1 in circulation
大体时间:24 hours after baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
24 hours after baseline
bdnf in circulation
大体时间:baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
baseline
bdnf in circulation
大体时间:up to 5 minutes post intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
up to 5 minutes post intervention
bdnf in circulation
大体时间:1 hour after intervention
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
1 hour after intervention
bdnf in circulation
大体时间:2 hours after intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
2 hours after intervention
bdnf in circulation
大体时间:24 hours after baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
24 hours after baseline
general executive functioning as assessed by the stroop test questionnaire
大体时间:baseline
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
baseline
general executive functioning as assessed by the stroop test questionnaire
大体时间:up to 5 minutes post intervention
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
up to 5 minutes post intervention
general executive functioning as assessed by the stroop test questionnaire
大体时间:1 hour after intervention
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
1 hour after intervention
general executive functioning as assessed by the stroop test questionnaire
大体时间:2 hours after intervention
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
2 hours after intervention
general executive functioning as assessed by the stroop test questionnaire
大体时间:24 hours after baseline
participants must identify the color of various words on the screen irrespective of their meaning, scored based on accuracy (0-100%) and reaction time in milliseconds
24 hours after baseline
general executive functioning as assessed by the flanker task questionnaire
大体时间:baseline
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
baseline
general executive functioning as assessed by the flanker task questionnaire
大体时间:up to 5 minutes post intervention
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
up to 5 minutes post intervention
general executive functioning as assessed by the flanker task questionnaire
大体时间:1 hour after intervention
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
1 hour after intervention
general executive functioning as assessed by the flanker task questionnaire
大体时间:2 hours after intervention
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
2 hours after intervention
general executive functioning as assessed by the flanker task questionnaire
大体时间:24 hours after baseline
participants must identify the orientation of a central arrow while ignoring those of other arrows on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
24 hours after baseline
general executive functioning as assessed by the irrelevant capture task questionnaire
大体时间:baseline
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
baseline
general executive functioning as assessed by the irrelevant capture task questionnaire
大体时间:up to 5 minutes post intervention
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
up to 5 minutes post intervention
general executive functioning as assessed by the irrelevant capture task questionnaire
大体时间:1 hour after intervention
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
1 hour after intervention
general executive functioning as assessed by the irrelevant capture task questionnaire
大体时间:2 hours after intervention
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
2 hours after intervention
general executive functioning as assessed by the irrelevant capture task questionnaire
大体时间:24 hours after baseline
participants must identify a set of symbols as either letters or numbers while ignoring distracting images that flash on the screen, scored based on accuracy (0-100%) and reaction time in milliseconds
24 hours after baseline

次要结果测量

结果测量
措施说明
大体时间
total and regional bone mass
大体时间:baseline
as assessed by dual-energy x-ray absorptiometry (DEXA) scan, in grams per square centimeter (g/cm2)
baseline
total and regional fat and fat-free mass
大体时间:baseline
as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
baseline
habitual activity levels
大体时间:baseline
as assessed by Rapid Assessment of Physical Activity questionnaire, possible scores are: Active, Under Active Regular, Under Active Regular- Light Activities, Under Active, Sedentary
baseline
muscle strength
大体时间:baseline
as measured by isokinetic testing using the Biodex System 3
baseline
cardiorespiratory endurance
大体时间:baseline
as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake
baseline
body mass index (BMI)
大体时间:baseline
measured in kilograms per square meter (kg/m2)
baseline
waist-to-hip ratio
大体时间:baseline
baseline

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:Peter Searson, PhD、Johns Hopkins University
  • 首席研究员:Kerry Stewart, EdD、Johns Hopkins University
  • 首席研究员:Howard Egeth, PhD、Johns Hopkins University

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 (实际的)

2016年8月1日

初级完成 (实际的)

2017年5月2日

研究完成 (实际的)

2017年5月2日

研究注册日期

首次提交

2016年10月31日

首先提交符合 QC 标准的

2016年11月4日

首次发布 (估计)

2016年11月8日

研究记录更新

最后更新发布 (实际的)

2017年8月18日

上次提交的符合 QC 标准的更新

2017年8月15日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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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