NCT02958735

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

October 31, 2016

Last Update Submit

August 15, 2017

Conditions

Keywords

exercisecognitionbrain-derived neurotrophic factorinsulin-like growth factor 1cortisol

Outcome Measures

Primary Outcomes (41)

  • visual short-term memory questionnaire

    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

    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

    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

    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

    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

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

    24 hours after baseline

  • verbal fluency

    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

    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

    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

    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

    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

    in nanograms per milliliter (ng/ml)

    baseline

  • cortisol in circulation

    in nanograms per milliliter (ng/ml)

    up to 5 minutes post intervention

  • cortisol in circulation

    in nanograms per milliliter (ng/ml)

    1 hour after intervention

  • cortisol in circulation

    in nanograms per milliliter (ng/ml)

    2 hours after intervention

  • cortisol in circulation

    in nanograms per milliliter (ng/ml)

    24 hours after baseline

  • igf-1 in circulation

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

    baseline

  • igf-1 in circulation

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

    up to 5 minutes post intervention

  • igf-1 in circulation

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

    1 hour after intervention

  • igf-1 in circulation

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

    2 hours after intervention

  • igf-1 in circulation

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

    24 hours after baseline

  • bdnf in circulation

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

    baseline

  • bdnf in circulation

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

    up to 5 minutes post intervention

  • bdnf in circulation

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

    1 hour after intervention

  • bdnf in circulation

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

    2 hours after intervention

  • bdnf in circulation

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

    24 hours after baseline

  • general executive functioning as assessed by the stroop test questionnaire

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Secondary Outcomes (7)

  • total and regional bone mass

    baseline

  • total and regional fat and fat-free mass

    baseline

  • habitual activity levels

    baseline

  • muscle strength

    baseline

  • cardiorespiratory endurance

    baseline

  • +2 more secondary outcomes

Study Arms (3)

Rest

NO INTERVENTION

Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge.

Mild Exercise

EXPERIMENTAL

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.

Other: Exercise Challenge

Hard Exercise

EXPERIMENTAL

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.

Other: Exercise Challenge

Interventions

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.

Hard ExerciseMild Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kerry Stewart, EdD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Peter Searson, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Howard Egeth, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 8, 2016

Study Start

August 1, 2016

Primary Completion

May 2, 2017

Study Completion

May 2, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations