이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Exercise and Cognition Trials (EXACT)

2017년 8월 15일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Baltimore, Maryland, 미국, 21224
        • Johns Hopkins Bayview Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
실험적: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
visual short-term memory questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 hours after baseline
participants encode images in a cover task at baseline, scored on accuracy (0-100%)
24 hours after baseline
verbal fluency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: baseline
in nanograms per milliliter (ng/ml)
baseline
cortisol in circulation
기간: up to 5 minutes post intervention
in nanograms per milliliter (ng/ml)
up to 5 minutes post intervention
cortisol in circulation
기간: 1 hour after intervention
in nanograms per milliliter (ng/ml)
1 hour after intervention
cortisol in circulation
기간: 2 hours after intervention
in nanograms per milliliter (ng/ml)
2 hours after intervention
cortisol in circulation
기간: 24 hours after baseline
in nanograms per milliliter (ng/ml)
24 hours after baseline
igf-1 in circulation
기간: baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
baseline
igf-1 in circulation
기간: 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
기간: 1 hour after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
1 hour after intervention
igf-1 in circulation
기간: 2 hours after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
2 hours after intervention
igf-1 in circulation
기간: 24 hours after baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
24 hours after baseline
bdnf in circulation
기간: baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
baseline
bdnf in circulation
기간: 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
기간: 1 hour after intervention
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
1 hour after intervention
bdnf in circulation
기간: 2 hours after intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
2 hours after intervention
bdnf in circulation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
total and regional bone mass
기간: 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
기간: baseline
as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
baseline
habitual activity levels
기간: 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
기간: baseline
as measured by isokinetic testing using the Biodex System 3
baseline
cardiorespiratory endurance
기간: baseline
as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake
baseline
body mass index (BMI)
기간: baseline
measured in kilograms per square meter (kg/m2)
baseline
waist-to-hip ratio
기간: baseline
baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Peter Searson, PhD, Johns Hopkins University
  • 수석 연구원: Kerry Stewart, EdD, Johns Hopkins University
  • 수석 연구원: Howard Egeth, PhD, Johns Hopkins University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 8월 1일

기본 완료 (실제)

2017년 5월 2일

연구 완료 (실제)

2017년 5월 2일

연구 등록 날짜

최초 제출

2016년 10월 31일

QC 기준을 충족하는 최초 제출

2016년 11월 4일

처음 게시됨 (추정)

2016년 11월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 8월 15일

마지막으로 확인됨

2017년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다