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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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

介入

入学 (実際)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Maryland
      • Baltimore、Maryland、アメリカ、21224
        • Johns Hopkins Bayview Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~40年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
visual short-term memory questionnaire
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:24 hours after baseline
participants encode images in a cover task at baseline, scored on accuracy (0-100%)
24 hours after baseline
verbal fluency
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:baseline
in nanograms per milliliter (ng/ml)
baseline
cortisol in circulation
時間枠:up to 5 minutes post intervention
in nanograms per milliliter (ng/ml)
up to 5 minutes post intervention
cortisol in circulation
時間枠:1 hour after intervention
in nanograms per milliliter (ng/ml)
1 hour after intervention
cortisol in circulation
時間枠:2 hours after intervention
in nanograms per milliliter (ng/ml)
2 hours after intervention
cortisol in circulation
時間枠:24 hours after baseline
in nanograms per milliliter (ng/ml)
24 hours after baseline
igf-1 in circulation
時間枠:baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
baseline
igf-1 in circulation
時間枠: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
時間枠:1 hour after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
1 hour after intervention
igf-1 in circulation
時間枠:2 hours after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
2 hours after intervention
igf-1 in circulation
時間枠:24 hours after baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
24 hours after baseline
bdnf in circulation
時間枠:baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
baseline
bdnf in circulation
時間枠: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
時間枠:1 hour after intervention
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
1 hour after intervention
bdnf in circulation
時間枠:2 hours after intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
2 hours after intervention
bdnf in circulation
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
total and regional bone mass
時間枠: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
時間枠:baseline
as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
baseline
habitual activity levels
時間枠: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
時間枠:baseline
as measured by isokinetic testing using the Biodex System 3
baseline
cardiorespiratory endurance
時間枠:baseline
as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake
baseline
body mass index (BMI)
時間枠:baseline
measured in kilograms per square meter (kg/m2)
baseline
waist-to-hip ratio
時間枠:baseline
baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Peter Searson, PhD、Johns Hopkins University
  • 主任研究者:Kerry Stewart, EdD、Johns Hopkins University
  • 主任研究者:Howard Egeth, PhD、Johns Hopkins University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年8月1日

一次修了 (実際)

2017年5月2日

研究の完了 (実際)

2017年5月2日

試験登録日

最初に提出

2016年10月31日

QC基準を満たした最初の提出物

2016年11月4日

最初の投稿 (見積もり)

2016年11月8日

学習記録の更新

投稿された最後の更新 (実際)

2017年8月18日

QC基準を満たした最後の更新が送信されました

2017年8月15日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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