Exercise and Cognition Trials (EXACT)
Human Performance: Role of Acute Exercise in Enhancing Cognitive Function
調査の概要
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
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins Bayview Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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 |
|---|---|
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介入なし:Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
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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.
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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.
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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.
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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.
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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 |
|---|---|---|
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visual short-term memory questionnaire
時間枠:baseline
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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%)
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baseline
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visual short-term memory questionnaire
時間枠:up to 5 minutes post intervention
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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%)
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up to 5 minutes post intervention
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visual short-term memory questionnaire
時間枠:1 hour after intervention
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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%)
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1 hour after intervention
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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%)
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2 hours after intervention
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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
|
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visual long-term memory questionnaire
時間枠:24 hours after baseline
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participants encode images in a cover task at baseline, scored on accuracy (0-100%)
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24 hours after baseline
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verbal fluency
時間枠:baseline
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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
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baseline
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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
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up to 5 minutes post intervention
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verbal fluency
時間枠:1 hour after intervention
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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
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1 hour after intervention
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verbal fluency
時間枠:2 hours after intervention
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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
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2 hours after intervention
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verbal fluency
時間枠:24 hours after baseline
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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
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24 hours after baseline
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cortisol in circulation
時間枠:baseline
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in nanograms per milliliter (ng/ml)
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baseline
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cortisol in circulation
時間枠:up to 5 minutes post intervention
|
in nanograms per milliliter (ng/ml)
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up to 5 minutes post intervention
|
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cortisol in circulation
時間枠:1 hour after intervention
|
in nanograms per milliliter (ng/ml)
|
1 hour after intervention
|
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cortisol in circulation
時間枠:2 hours after intervention
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in nanograms per milliliter (ng/ml)
|
2 hours after intervention
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cortisol in circulation
時間枠:24 hours after baseline
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in nanograms per milliliter (ng/ml)
|
24 hours after baseline
|
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igf-1 in circulation
時間枠:baseline
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insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
baseline
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igf-1 in circulation
時間枠:up to 5 minutes post intervention
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insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
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up to 5 minutes post intervention
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igf-1 in circulation
時間枠:1 hour after intervention
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insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
|
1 hour after intervention
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igf-1 in circulation
時間枠:2 hours after intervention
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insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
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2 hours after intervention
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igf-1 in circulation
時間枠:24 hours after baseline
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insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
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24 hours after baseline
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bdnf in circulation
時間枠:baseline
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brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
baseline
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bdnf in circulation
時間枠:up to 5 minutes post intervention
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brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
up to 5 minutes post intervention
|
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bdnf in circulation
時間枠:1 hour after intervention
|
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
1 hour after intervention
|
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bdnf in circulation
時間枠:2 hours after intervention
|
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
|
2 hours after intervention
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bdnf in circulation
時間枠:24 hours after baseline
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brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
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24 hours after baseline
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general executive functioning as assessed by the stroop test questionnaire
時間枠:baseline
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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
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baseline
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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
|
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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
|
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general executive functioning as assessed by the flanker task questionnaire
時間枠:baseline
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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
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baseline
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general executive functioning as assessed by the flanker task questionnaire
時間枠:up to 5 minutes post intervention
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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
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up to 5 minutes post intervention
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general executive functioning as assessed by the flanker task questionnaire
時間枠:1 hour after intervention
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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
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1 hour after intervention
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general executive functioning as assessed by the flanker task questionnaire
時間枠:2 hours after intervention
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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
|
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general executive functioning as assessed by the flanker task questionnaire
時間枠:24 hours after baseline
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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
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general executive functioning as assessed by the irrelevant capture task questionnaire
時間枠:baseline
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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
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baseline
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general executive functioning as assessed by the irrelevant capture task questionnaire
時間枠:up to 5 minutes post intervention
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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
|
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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
|
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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
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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total and regional bone mass
時間枠:baseline
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as assessed by dual-energy x-ray absorptiometry (DEXA) scan, in grams per square centimeter (g/cm2)
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baseline
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total and regional fat and fat-free mass
時間枠:baseline
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as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
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baseline
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habitual activity levels
時間枠:baseline
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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
|
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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
|
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body mass index (BMI)
時間枠:baseline
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measured in kilograms per square meter (kg/m2)
|
baseline
|
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waist-to-hip ratio
時間枠:baseline
|
baseline
|
協力者と研究者
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
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRB00076336
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?
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