Skip to main content
OpenTrials
Completed

NCT Number: NCT02958735

Exercise and Cognition Trials

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alteration of Cognitive Function Behavior Motor Activity

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Challenge

Other

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.

Primary outcomes

  1. visual short-term memory questionnaire

    Time frame: 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%)

  2. visual short-term memory questionnaire

    Time frame: 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%)

  3. visual short-term memory questionnaire

    Time frame: 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%)

  4. visual short-term memory questionnaire

    Time frame: 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%)

  5. visual short-term memory questionnaire

    Time frame: 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%)

  6. visual long-term memory questionnaire

    Time frame: 24 hours after baseline

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

  7. verbal fluency

    Time frame: 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

  8. verbal fluency

    Time frame: 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

  9. verbal fluency

    Time frame: 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

  10. verbal fluency

    Time frame: 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

  11. verbal fluency

    Time frame: 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

  12. cortisol in circulation

    Time frame: baseline

    in nanograms per milliliter (ng/ml)

  13. cortisol in circulation

    Time frame: up to 5 minutes post intervention

    in nanograms per milliliter (ng/ml)

  14. cortisol in circulation

    Time frame: 1 hour after intervention

    in nanograms per milliliter (ng/ml)

  15. cortisol in circulation

    Time frame: 2 hours after intervention

    in nanograms per milliliter (ng/ml)

  16. cortisol in circulation

    Time frame: 24 hours after baseline

    in nanograms per milliliter (ng/ml)

  17. igf-1 in circulation

    Time frame: baseline

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

  18. igf-1 in circulation

    Time frame: up to 5 minutes post intervention

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

  19. igf-1 in circulation

    Time frame: 1 hour after intervention

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

  20. igf-1 in circulation

    Time frame: 2 hours after intervention

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

  21. igf-1 in circulation

    Time frame: 24 hours after baseline

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

  22. bdnf in circulation

    Time frame: baseline

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

  23. bdnf in circulation

    Time frame: up to 5 minutes post intervention

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

  24. bdnf in circulation

    Time frame: 1 hour after intervention

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

  25. bdnf in circulation

    Time frame: 2 hours after intervention

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

  26. bdnf in circulation

    Time frame: 24 hours after baseline

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

  27. general executive functioning as assessed by the stroop test questionnaire

    Time frame: 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

  28. general executive functioning as assessed by the stroop test questionnaire

    Time frame: 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

  29. general executive functioning as assessed by the stroop test questionnaire

    Time frame: 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

  30. general executive functioning as assessed by the stroop test questionnaire

    Time frame: 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

  31. general executive functioning as assessed by the stroop test questionnaire

    Time frame: 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

  32. general executive functioning as assessed by the flanker task questionnaire

    Time frame: 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

  33. general executive functioning as assessed by the flanker task questionnaire

    Time frame: 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

  34. general executive functioning as assessed by the flanker task questionnaire

    Time frame: 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

  35. general executive functioning as assessed by the flanker task questionnaire

    Time frame: 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

  36. general executive functioning as assessed by the flanker task questionnaire

    Time frame: 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

  37. general executive functioning as assessed by the irrelevant capture task questionnaire

    Time frame: 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

  38. general executive functioning as assessed by the irrelevant capture task questionnaire

    Time frame: 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

  39. general executive functioning as assessed by the irrelevant capture task questionnaire

    Time frame: 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

  40. general executive functioning as assessed by the irrelevant capture task questionnaire

    Time frame: 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

  41. general executive functioning as assessed by the irrelevant capture task questionnaire

    Time frame: 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

Secondary outcomes

  1. total and regional bone mass

    Time frame: baseline

    as assessed by dual-energy x-ray absorptiometry (DEXA) scan, in grams per square centimeter (g/cm2)

  2. total and regional fat and fat-free mass

    Time frame: baseline

    as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)

  3. habitual activity levels

    Time frame: 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

  4. muscle strength

    Time frame: baseline

    as measured by isokinetic testing using the Biodex System 3

  5. cardiorespiratory endurance

    Time frame: baseline

    as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake

  6. body mass index (BMI)

    Time frame: baseline

    measured in kilograms per square meter (kg/m2)

  7. waist-to-hip ratio

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Human Performance: Role of Acute Exercise in Enhancing Cognitive Function

Acronym: EXACT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.