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Exercise and Cognition Trials (EXACT)

15. srpna 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Maryland
      • Baltimore, Maryland, Spojené státy, 21224
        • Johns Hopkins Bayview Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 40 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Rest
Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.
Experimentální: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

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

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Peter Searson, PhD, Johns Hopkins University
  • Vrchní vyšetřovatel: Kerry Stewart, EdD, Johns Hopkins University
  • Vrchní vyšetřovatel: Howard Egeth, PhD, Johns Hopkins University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2016

Primární dokončení (Aktuální)

2. května 2017

Dokončení studie (Aktuální)

2. května 2017

Termíny zápisu do studia

První předloženo

31. října 2016

První předloženo, které splnilo kritéria kontroly kvality

4. listopadu 2016

První zveřejněno (Odhad)

8. listopadu 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. srpna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. srpna 2017

Naposledy ověřeno

1. srpna 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • IRB00076336

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