CognitionPhase 3NCT00430976
Exercise, Executive Processes and the Aging Brain
A Phase 3 study testing Minds in Motion in people with Cognition and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of aerobic exercise on the brain and cognition through the measurement of neuroelectric and behavioral indices of executive control cognitive function in older adults. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- What is being tested?
- Minds in Motion
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2007
- Phase
- Phase 3
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-74 years of age
- Sedentary (no physical activity in 6 last months)
- Capable of performing exercise
- Personal physician's examination and consent to participate in testing and exercise or control intervention
- Successful completion of graded exercise test without evidence of cardiac abnormalities or responses
- Adequate performance on the Mental Status measure
Show all 9Show fewer
- Corrected (near and far) acuity 20/40 or better
- Initial depression score on GDS below clinical level
- Not previously committed to leaving the Champaign County area for more than 1 month during the intervention period
Who cannot join
- Below 60 years of age
- Regular self-reported physical activity (2 times per week) in last six months
- Any physical disability that prohibits mobility (walking), stretching etc.
- Non-consent of physician
- Evidence of abnormal cardiac responses or conditions during graded exercise testing
- Three or more errors on the Mental Status measure
Show all 9Show fewer
- Corrected (near and far) acuity of greater than 20/40
- Depression score on GDS indicative of clinical depression
- Committed to leaving the Champaign County area for longer than 1 month during the intervention period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
The purpose of this study is to assess the effect of aerobic exercise on the brain and cognition through the measurement of neuroelectric and behavioral indices of executive control cognitive function in older adults.
Read the detailed description
The aim of this research is to gain a better understanding of factors that relate to the increased health and effective functioning of older adults. Specifically, efficiency of psychomotor performance declines with advancing age leading to profound effects on older adults' quality of life. For this reason, researchers have focused on the influence that individual lifestyle habits have on the aging process. One lifestyle choice that has been found to positively contribute to the efficiency of older adults' psychomotor performance is cardiovascular exercise. This relationship appears to be especially significant when older adults are challenged with more complex or effortful tasks. Previous research has led investigators to believe that aging has a specific, rather than generalized, impact on cognitive functioning. Also, prolonged participation in cardiovascular exercise has been found to maintain the cognitive functioning critical for healthy aging.
Therefore, the purpose of this research is to examine the role of an organized 6-month cardiovascular exercise intervention trial on electrocortical (event-related brain potential) and behavioral measures (reaction time) of executive control. In addition, a non-cardiovascular exercise control group that participates in a 6-month stretching and toning program will be used for comparison. Participants will be measured before and after exercise training during engagement in several tasks designed to elicit different executive functions (e.g., discrimination, task switching, inhibition). Each task also contains a non-executive condition that will be used for comparison to examine the specificity of exercise participation of cognitive functioning. A secondary aim of this project is to determine the effects of an acute bout of exercise on cognitive functioning. Both groups will participate in several bouts of exercise followed by immediate measurement on the tasks outlined above to determine whether acute exercise has beneficial effects on executive processes. The significance of this research may include the increased understanding of factors related to the amelioration of age-related decrements in central nervous system functioning and recommendations for the maintenance of cognitive health during the later stages of life.
- Being tested
- Minds in Motion
- Keywords
- psychomotor function, neuromuscular system, memory, brain electrical activity, Mental Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minds in MotionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in event-related brain potentials
reaction time
response accuracy
Secondary outcomes (1)
aerobic fitness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2007
- Study completionMay 2007
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 CognitionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Charles H. Hillman, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430976
- Sponsor's protocol ID
- IA0101
- Other IDs
- 5R01AG021188-03
- Status last verified
- Aug 2008
- First submitted
- 31 Jan 2007
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Themanson JR, Hillman CH, Curtin JJ. Age and physical activity influences on action monitoring during task switching. Neurobiol Aging. 2006 Sep;27(9):1335-45. doi: 10.1016/j.neurobiolaging.2005.07.002. Epub 2005 Aug 15.
PubMed 16102874Hillman CH, Motl RW, Pontifex MB, Posthuma D, Stubbe JH, Boomsma DI, de Geus EJC. Physical activity and cognitive function in a cross-section of younger and older community-dwelling individuals. Health Psychol. 2006 Nov;25(6):678-687. doi: 10.1037/0278-6133.25.6.678.
PubMed 17100496Hillman CH, Kramer AF, Belopolsky AV, Smith DP. A cross-sectional examination of age and physical activity on performance and event-related brain potentials in a task switching paradigm. Int J Psychophysiol. 2006 Jan;59(1):30-9. doi: 10.1016/j.ijpsycho.2005.04.009.
PubMed 16413382
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise, Executive Processes and the Aging Brain
- ClinicalTrials.gov ID
- NCT00430976
- Acronym / sponsor ID
- IA0101
- Keywords
- psychomotor function, neuromuscular system, memory, brain electrical activity, Mental Processes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Dec 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Feb 2007 (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 assess the effect of aerobic exercise on the brain and cognition through the measurement of neuroelectric and behavioral indices of executive control cognitive function in older adults.
Detailed description
The aim of this research is to gain a better understanding of factors that relate to the increased health and effective functioning of older adults. Specifically, efficiency of psychomotor performance declines with advancing age leading to profound effects on older adults' quality of life. For this reason, researchers have focused on the influence that individual lifestyle habits have on the aging process. One lifestyle choice that has been found to positively contribute to the efficiency of older adults' psychomotor performance is cardiovascular exercise. This relationship appears to be especially significant when older adults are challenged with more complex or effortful tasks. Previous research has led investigators to believe that aging has a specific, rather than generalized, impact on cognitive functioning. Also, prolonged participation in cardiovascular exercise has been found to maintain the cognitive functioning critical for healthy aging.
Therefore, the purpose of this research is to examine the role of an organized 6-month cardiovascular exercise intervention trial on electrocortical (event-related brain potential) and behavioral measures (reaction time) of executive control. In addition, a non-cardiovascular exercise control group that participates in a 6-month stretching and toning program will be used for comparison. Participants will be measured before and after exercise training during engagement in several tasks designed to elicit different executive functions (e.g., discrimination, task switching, inhibition). Each task also contains a non-executive condition that will be used for comparison to examine the specificity of exercise participation of cognitive functioning. A secondary aim of this project is to determine the effects of an acute bout of exercise on cognitive functioning. Both groups will participate in several bouts of exercise followed by immediate measurement on the tasks outlined above to determine whether acute exercise has beneficial effects on executive processes. The significance of this research may include the increased understanding of factors related to the amelioration of age-related decrements in central nervous system functioning and recommendations for the maintenance of cognitive health during the later stages of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 60-74 years of age
- Sedentary (no physical activity in 6 last months)
- Capable of performing exercise
- Personal physician's examination and consent to participate in testing and exercise or control intervention
- Successful completion of graded exercise test without evidence of cardiac abnormalities or responses
Key exclusion criteria (9 listed)
- Below 60 years of age
- Regular self-reported physical activity (2 times per week) in last six months
- Any physical disability that prohibits mobility (walking), stretching etc.
- Non-consent of physician
- Evidence of abnormal cardiac responses or conditions during graded exercise testing
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 |
|---|---|---|
| Minds in Motion | Behavioural | – |
Primary outcome
Changes in event-related brain potentials
reaction time
response accuracy
1 secondary outcome
aerobic fitness
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 11 Dec 2009.
- Background: PubMed 16102874Themanson JR, Hillman CH, Curtin JJ. Age and physical activity influences on action monitoring during task switching. Neurobiol Aging. 2006 Sep;27(9):1335-45. doi: 10.1016/j.neurobiolaging.2005.07.002. Epub 2005 Aug 15.
- Background: PubMed 17100496Hillman CH, Motl RW, Pontifex MB, Posthuma D, Stubbe JH, Boomsma DI, de Geus EJC. Physical activity and cognitive function in a cross-section of younger and older community-dwelling individuals. Health Psychol. 2006 Nov;25(6):678-687. doi: 10.1037/0278-6133.25.6.678.
- Background: PubMed 16413382Hillman CH, Kramer AF, Belopolsky AV, Smith DP. A cross-sectional examination of age and physical activity on performance and event-related brain potentials in a task switching paradigm. Int J Psychophysiol. 2006 Jan;59(1):30-9. doi: 10.1016/j.ijpsycho.2005.04.009.
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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.
Charles H. Hillman, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minds in Motion in people with Cognition and Aging, run by National Institute on Aging (NIA) 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 9 inclusion and 9 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 11 Dec 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Changes in event-related brain potentials. The study lists 3 primary outcomes in all. 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 NCT00430976, 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 11 Dec 2009.