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临床试验/NCT02958735
NCT02958735已完成不适用

Human Performance: Role of Acute Exercise in Enhancing Cognitive Function

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
general executive functioning as assessed by the stroop test questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Rest

No Intervention

Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.

Mild Exercise

Experimental

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.

干预措施: Exercise Challenge (Other)

Hard Exercise

Experimental

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.

干预措施: Exercise Challenge (Other)

结局指标

主要结局

general executive functioning as assessed by the stroop test questionnaire

时间窗: 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

visual short-term memory questionnaire

时间窗: 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%)

verbal fluency

时间窗: 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

bdnf in circulation

时间窗: 24 hours after baseline

brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)

general executive functioning as assessed by the irrelevant capture task questionnaire

时间窗: 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

visual long-term memory questionnaire

时间窗: 24 hours after baseline

participants encode images in a cover task at baseline, scored on accuracy (0-100%)

cortisol in circulation

时间窗: 24 hours after baseline

in nanograms per milliliter (ng/ml)

igf-1 in circulation

时间窗: 24 hours after baseline

insulin-like growth factor 1 in nanograms per milliliter (ng/ml)

general executive functioning as assessed by the flanker task questionnaire

时间窗: 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

igf-1 in circulation

时间窗: 2 hours after intervention

insulin-like growth factor 1 in nanograms per milliliter (ng/ml)

visual short-term memory questionnaire

时间窗: 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%)

visual short-term memory questionnaire

时间窗: 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%)

visual short-term memory questionnaire

时间窗: 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%)

visual short-term memory questionnaire

时间窗: 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%)

verbal fluency

时间窗: 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

verbal fluency

时间窗: 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

verbal fluency

时间窗: 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

verbal fluency

时间窗: 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

cortisol in circulation

时间窗: baseline

in nanograms per milliliter (ng/ml)

cortisol in circulation

时间窗: up to 5 minutes post intervention

in nanograms per milliliter (ng/ml)

cortisol in circulation

时间窗: 1 hour after intervention

in nanograms per milliliter (ng/ml)

cortisol in circulation

时间窗: 2 hours after intervention

in nanograms per milliliter (ng/ml)

igf-1 in circulation

时间窗: baseline

insulin-like growth factor 1 in nanograms per milliliter (ng/ml)

igf-1 in circulation

时间窗: up to 5 minutes post intervention

insulin-like growth factor 1 in nanograms per milliliter (ng/ml)

igf-1 in circulation

时间窗: 1 hour after intervention

insulin-like growth factor 1 in nanograms per milliliter (ng/ml)

bdnf in circulation

时间窗: baseline

brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)

bdnf in circulation

时间窗: up to 5 minutes post intervention

brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)

bdnf in circulation

时间窗: 1 hour after intervention

brain derived neurotrophic factor in nanograms per milliliter (ng/ml)

bdnf in circulation

时间窗: 2 hours after intervention

brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)

general executive functioning as assessed by the stroop test questionnaire

时间窗: 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

general executive functioning as assessed by the stroop test questionnaire

时间窗: 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

general executive functioning as assessed by the stroop test questionnaire

时间窗: 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

general executive functioning as assessed by the stroop test questionnaire

时间窗: 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

general executive functioning as assessed by the flanker task questionnaire

时间窗: 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

general executive functioning as assessed by the flanker task questionnaire

时间窗: 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

general executive functioning as assessed by the flanker task questionnaire

时间窗: 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

general executive functioning as assessed by the flanker task questionnaire

时间窗: 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

general executive functioning as assessed by the irrelevant capture task questionnaire

时间窗: 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

general executive functioning as assessed by the irrelevant capture task questionnaire

时间窗: 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

general executive functioning as assessed by the irrelevant capture task questionnaire

时间窗: 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

general executive functioning as assessed by the irrelevant capture task questionnaire

时间窗: 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

次要结局

  • cardiorespiratory endurance(baseline)
  • total and regional fat and fat-free mass(baseline)
  • total and regional bone mass(baseline)
  • habitual activity levels(baseline)
  • muscle strength(baseline)
  • body mass index (BMI)(baseline)
  • waist-to-hip ratio(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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