Traumatic Brain InjuryPhase 1NCT01939769
Effects of Exercise on Memory in Healthy and Brain-Injured Individuals
A Phase 1 study testing Exercise - Low-intensity exercise and Exercise - High-intensity exercise in people with Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Research has shown that one exercise session may improve a person s ability to recall information they learned before the exercise. Knowing how exercise changes brain activity to improve memory can help researchers understand how memory works and how to improve it in people with memory problems. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Exercise - Low-intensity exercise and Exercise - High-intensity exercise
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2013to 28 Aug 2017
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- <TAB>
- Age 18-45 (inclusive)
- English speaking and writing
- For TBI patients:<TAB>
- History of TBI (defined according to the American Congress of Rehabilitation Medicine Criteria: History of having sustained a traumatically induced physiological disruption of brain function at least 2 months before participation)
- Evidence of at least moderate TBI severity. Evidence for intensity of TBI will be any one of the following 3 criteria:
Show all 12Show fewer
- GCS greater than or equal to 9 (obtained in Emergency Room and noted in medical record)
- Post-traumatic amnesia > 24 hours
- TBI-related abnormality on neuroimaging (either CT or MRI)
- Documented memory deficit, i.e., a score of 1 standard deviation or more below age-adjusted norm on a recognized clinical test of memory, such as the Wexler Memory Scale, within the last two years.
- Enrollment in Protocol 11-N-0084
- Right-handedness for fMRI participants
Who cannot join
- Inability to give informed consent
- History of major neurological or psychiatric illness, e.g., neurodegenerative disorder, stroke, congenital or genetic disorder, currently symptomatic major depressive disorder, schizophrenia
- History of exercise intolerance
- Any finding on examination indicative of cardiac or respiratory compromise
- History of heart disease
- History of pulmonary disease, other than controlled, non-exercise-induced asthma
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- History of uncontrolled diabetes
- Resting heart rate > 100 BPM
- Resting systolic blood pressure > 140 mmHg or diastolic blood pressure > 100 mmHg
- Peripheral condition making completion of the exercise protocol impossible, such as severe osteoarthritis or chronic pain
- Pregnancy
- For healthy subjects undergoing MRI:
- Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
- Implanted cardiac pacemaker or auto-defibrillator or pump
- Non-removable body piercing
- Claustrophobia
- Inability to lie supine for two hours
- Any structural brain abnormality, such as tumor or stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Acute Effects of Exercise on Memory in Healthy and Brain-Injured Individuals
Background:
- Research has shown that one exercise session may improve a person s ability to recall information they learned before the exercise. Knowing how exercise changes brain activity to improve memory can help researchers understand how memory works and how to improve it in people with memory problems. This study compares two kinds of exercise on a stationary bike for their ability to temporarily improve memory on certain tests. Researchers will look at the effect of exercise on body chemistry by drawing blood and collecting saliva.
Read more
Objectives:
- To understand how a single session of exercise affects memory testing in healthy people and people who have had traumatic brain injury (TBI).
Eligibility:
- Adults ages 18 through 45 with TBI.
- Healthy adult volunteers, ages 18 through 45.
Design:
- Participants will be screened with medical history and physical exam. This will take about 1 hour.
- Participants with TBI will also be screened with a test of their memory. This will take another hour.
- Visit 1 will take about 3 hours. Participants will:
<TAB>- Have a tube inserted in their arm for drawing blood during the tests.
<TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer questions.
<TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.
<TAB>- Exercise on a stationary bike.
<TAB>- Take the memory tests again.
- Visit 2 will take place 1 week later. Participants will take the memory tests only.
Read the detailed description
Objective: The goals of this study are to 1. replicate the finding that exercise after exposure to images enhances their subsequent recall, 2. extend the question to words and logical rules, 3. examine the mechanism of the effect using exercise biomarkers and fMRI and 4. explore its usefulness as an aid to memory in individuals with traumatic brain injury (TBI).
Study population: Healthy adult volunteers and individuals with TBI.
Design: The main, clinical, experiment has a parallel, repeated-measures design, where four groups (two each of healthy subjects and participants with TBI) will encode pictures, words and rules and then exercise at either a high or very low (placebo) intensity. Recall will be tested one hour and again at seven days after exercise. Blood and saliva will be collected before and immediately after exercise and assayed for biomarkers of exercise, thought to be possible mediators of the memory effect. In a parallel-design fMRI experiment, intended to explore the brain basis of the effect of exercise on memory, healthy volunteers will view pictures, exercise at a high or low intensity, and then perform a recall task in the scanner. The analysis will look for differences in location and extent of evoked brain activations evoked by picture recall after low and high intensity exercise.
Outcome measures: The primary outcome measure is recall of visual material one hour after exercise. Secondary measures will be the recall of word lists and letter/digit symbol matching (logical memory) and activations on fMRI. The blood and saliva biomarkers will are included as exploratory outcomes.
- Conditions
- Traumatic Brain Injury
- Being tested
- Exercise - Low-intensity exercise, Exercise - High-intensity exercise
- Keywords
- fMRI, Catecholamines, Stress, Exercise, Memory
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise - Low-intensity exerciseOther
Exercise - High-intensity exerciseOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of pictures
Measured: 2 years
Secondary outcomes (2)
Recall of word lists
Measured: 2 years
Digit-symbol substitution performance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study start31 Aug 2013
- Primary completion21 May 2015
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939769
- Sponsor's protocol ID
- 130198
- Other IDs
- 13-N-0198
- Status last verified
- 28 Aug 2017
- First submitted
- 6 Sep 2013
- Last updated
- 30 Aug 2017
- Results posted
- No
Publications
Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.
PubMed 21878600Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.
PubMed 5523831
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Exercise on Memory in Healthy and Brain-Injured Individuals
- ClinicalTrials.gov ID
- NCT01939769
- Acronym / sponsor ID
- 130198
- Conditions
- Traumatic Brain Injury
- Keywords
- fMRI, Catecholamines, Stress, Exercise, Memory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 31 Aug 2013
- Primary completion
- 21 May 2015 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 11 Sep 2013 (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.
Background:
- Research has shown that one exercise session may improve a person s ability to recall information they learned before the exercise. Knowing how exercise changes brain activity to improve memory can help researchers understand how memory works and how to improve it in people with memory problems. This study compares two kinds of exercise on a stationary bike for their ability to temporarily improve memory on certain tests. Researchers will look at the effect of exercise on body chemistry by drawing blood and collecting saliva.
Objectives:
- To understand how a single session of exercise affects memory testing in healthy people and people who have had traumatic brain injury (TBI).
Eligibility:
- Adults ages 18 through 45 with TBI.
- Healthy adult volunteers, ages 18 through 45.
Design:
- Participants will be screened with medical history and physical exam. This will take about 1 hour.
- Participants with TBI will also be screened with a test of their memory. This will take another hour.
- Visit 1 will take about 3 hours. Participants will:
<TAB>- Have a tube inserted in their arm for drawing blood during the tests.
<TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer questions.
<TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.
<TAB>- Exercise on a stationary bike.
<TAB>- Take the memory tests again.
- Visit 2 will take place 1 week later. Participants will take the memory tests only.
Detailed description
Objective: The goals of this study are to 1. replicate the finding that exercise after exposure to images enhances their subsequent recall, 2. extend the question to words and logical rules, 3. examine the mechanism of the effect using exercise biomarkers and fMRI and 4. explore its usefulness as an aid to memory in individuals with traumatic brain injury (TBI).
Study population: Healthy adult volunteers and individuals with TBI.
Design: The main, clinical, experiment has a parallel, repeated-measures design, where four groups (two each of healthy subjects and participants with TBI) will encode pictures, words and rules and then exercise at either a high or very low (placebo) intensity. Recall will be tested one hour and again at seven days after exercise. Blood and saliva will be collected before and immediately after exercise and assayed for biomarkers of exercise, thought to be possible mediators of the memory effect. In a parallel-design fMRI experiment, intended to explore the brain basis of the effect of exercise on memory, healthy volunteers will view pictures, exercise at a high or low intensity, and then perform a recall task in the scanner. The analysis will look for differences in location and extent of evoked brain activations evoked by picture recall after low and high intensity exercise.
Outcome measures: The primary outcome measure is recall of visual material one hour after exercise. Secondary measures will be the recall of word lists and letter/digit symbol matching (logical memory) and activations on fMRI. The blood and saliva biomarkers will are included as exploratory outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- <TAB>
- Age 18-45 (inclusive)
- English speaking and writing
- For TBI patients:<TAB>
- Right-handedness for fMRI participants
Key exclusion criteria (18 listed)
- Inability to give informed consent
- History of major neurological or psychiatric illness, e.g., neurodegenerative disorder, stroke, congenital or genetic disorder, currently symptomatic major depressive disorder, schizophrenia
- History of exercise intolerance
- Any finding on examination indicative of cardiac or respiratory compromise
- History of heart disease
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 - Low-intensity exercise | Other | – |
| Exercise - High-intensity exercise | Other | – |
Primary outcome
Recall of pictures
Time frame: 2 years
2 secondary outcomes
Recall of word lists
Time frame: 2 years
Digit-symbol substitution performance
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 21878600Ahlskog JE, Geda YE, Graff-Radford NR, Petersen RC. Physical exercise as a preventive or disease-modifying treatment of dementia and brain aging. Mayo Clin Proc. 2011 Sep;86(9):876-84. doi: 10.4065/mcp.2011.0252.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 5523831Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.
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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.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise - Low-intensity exercise and Exercise - High-intensity exercise in people with Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 12 inclusion and 18 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: stopped early, as of the sponsor's last update on 30 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Recall of pictures (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01939769, which also lists 3 linked publications.
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 30 Aug 2017.