Alteration of Cognitive FunctionEXACTNCT02958735
Exercise and Cognition Trials
A study testing Exercise Challenge in people with Alteration of Cognitive Function, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function
- What is being tested?
- Exercise Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 2 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Alteration of Cognitive Function
- Being tested
- Exercise Challenge
- Keywords
- exercise, cognition, brain-derived neurotrophic factor, insulin-like growth factor 1, cortisol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ChallengeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 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%)
Measured: 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%)
Measured: 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%)
Measured: 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%)
Measured: 24 hours after baseline
visual long-term memory questionnaire
participants encode images in a cover task at baseline, scored on accuracy (0-100%)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after baseline
cortisol in circulation
in nanograms per milliliter (ng/ml)
Measured: baseline
cortisol in circulation
in nanograms per milliliter (ng/ml)
Measured: up to 5 minutes post intervention
cortisol in circulation
in nanograms per milliliter (ng/ml)
Measured: 1 hour after intervention
cortisol in circulation
in nanograms per milliliter (ng/ml)
Measured: 2 hours after intervention
cortisol in circulation
in nanograms per milliliter (ng/ml)
Measured: 24 hours after baseline
igf-1 in circulation
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
Measured: baseline
igf-1 in circulation
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
Measured: up to 5 minutes post intervention
igf-1 in circulation
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
Measured: 1 hour after intervention
igf-1 in circulation
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
Measured: 2 hours after intervention
igf-1 in circulation
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
Measured: 24 hours after baseline
bdnf in circulation
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
Measured: baseline
bdnf in circulation
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
Measured: up to 5 minutes post intervention
bdnf in circulation
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
Measured: 1 hour after intervention
bdnf in circulation
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
Measured: 2 hours after intervention
bdnf in circulation
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after baseline
Secondary outcomes (7)
total and regional bone mass
as assessed by dual-energy x-ray absorptiometry (DEXA) scan, in grams per square centimeter (g/cm2)
Measured: baseline
total and regional fat and fat-free mass
as assessed by dual-energy x-ray absorptiometry (DEXA) scan in grams per square centimeter (g/cm2)
Measured: baseline
habitual activity levels
as assessed by Rapid Assessment of Physical Activity questionnaire, possible scores are: Active, Under Active Regular, Under Active Regular- Light Activities, Under Active, Sedentary
Measured: baseline
muscle strength
as measured by isokinetic testing using the Biodex System 3
Measured: baseline
cardiorespiratory endurance
as assessed by maximal stress test, represented by heart rate at maximal oxygen uptake
Measured: baseline
body mass index (BMI)
measured in kilograms per square meter (kg/m2)
Measured: baseline
waist-to-hip ratio
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start1 Aug 2016
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alteration of Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry Stewart, EdD, Principal investigator, Johns Hopkins UniversityPeter Searson, PhD, Principal investigator, Johns Hopkins UniversityHoward Egeth, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958735
- Sponsor's protocol ID
- IRB00076336
- Acronym
- EXACT
- Status last verified
- Aug 2017
- First submitted
- 31 Oct 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Performance: Role of Acute Exercise in Enhancing Cognitive Function
- ClinicalTrials.gov ID
- NCT02958735
- Acronym / sponsor ID
- EXACT / IRB00076336
- Conditions
- Alteration of Cognitive Function
- Keywords
- exercise, cognition, brain-derived neurotrophic factor, insulin-like growth factor 1, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rest | No intervention | –Participants randomly assigned to this arm rest quietly for thirty minutes instead of participating in the exercise challenge. |
| Mild Exercise | Experimental | Other: Exercise ChallengeParticipants 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. |
| Hard Exercise | Experimental | Other: Exercise ChallengeParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ChallengeParticipants 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. | Other | Hard Exercise, Mild Exercise |
Primary outcome
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%)
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%)
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%)
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%)
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%)
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%)
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
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
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
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
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
cortisol in circulation
Time frame: baseline
in nanograms per milliliter (ng/ml)
cortisol in circulation
Time frame: up to 5 minutes post intervention
in nanograms per milliliter (ng/ml)
cortisol in circulation
Time frame: 1 hour after intervention
in nanograms per milliliter (ng/ml)
cortisol in circulation
Time frame: 2 hours after intervention
in nanograms per milliliter (ng/ml)
cortisol in circulation
Time frame: 24 hours after baseline
in nanograms per milliliter (ng/ml)
igf-1 in circulation
Time frame: baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
igf-1 in circulation
Time frame: up to 5 minutes post intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
igf-1 in circulation
Time frame: 1 hour after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
igf-1 in circulation
Time frame: 2 hours after intervention
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
igf-1 in circulation
Time frame: 24 hours after baseline
insulin-like growth factor 1 in nanograms per milliliter (ng/ml)
bdnf in circulation
Time frame: baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
bdnf in circulation
Time frame: up to 5 minutes post intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
bdnf in circulation
Time frame: 1 hour after intervention
brain derived neurotrophic factor in nanograms per milliliter (ng/ml)
bdnf in circulation
Time frame: 2 hours after intervention
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
bdnf in circulation
Time frame: 24 hours after baseline
brain-derived neurotrophic factor in nanograms per milliliter (ng/ml)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
7 secondary outcomes
total and regional bone mass
Time frame: baseline
total and regional fat and fat-free mass
Time frame: baseline
habitual activity levels
Time frame: baseline
muscle strength
Time frame: baseline
cardiorespiratory endurance
Time frame: baseline
body mass index (BMI)
Time frame: baseline
waist-to-hip ratio
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry Stewart, EdD principal investigator
Johns Hopkins University
Peter Searson, PhD principal investigator
Johns Hopkins University
Howard Egeth, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Challenge in people with Alteration of Cognitive Function, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual short-term memory questionnaire (time frame: baseline). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017; AzTrials last refreshed its copy on 29 Oct 2026.