AgingNCT00438347
Influence of Fitness on Brain and Cognition
An observational study of Aging and Cognitive Ability, General, run by University of Illinois at Urbana-Champaign at 2 sites in United States.
Trial summary
The purpose of this study is to examine the effect of aerobic fitness training on human cognition, brain structure, and brain function of older adults. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Ability, General
- What is being tested?
- Aerobic Exercise and Stretching and toning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to May 2012
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults over 60
Who may be able to join
- 60 to 75 years of age (for Sedentary Older Adults)
- Sedentary Older Adults: no physical activity in last six months; Young Comparison Sample: Moderately active lifestyle
- 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 Pfeiffer (1979) Mental Status measure - Corrected (near and far) vision 20/40 or better
- Right-handed
- Intention to remain in the local area over the study period
Who cannot join
- Sedentary Older Adults: self reported physical activity on regular basis (2 times or more per week) in last six months; Young Comparison Sample: sedentary or highly active/athletic lifestyle
- Any physical disability that prohibits mobility (walking), stretching etc.
- Depression score on GDS indicative of clinical depression
- Presence of any implanted devices such as cardiac pacemakers or autodefibrillators; neural pacemakers, aneurysm clips in the CNS; cochlear implants; metallic bodies in the eye or CNS; any form of wires or metal devices that concentrate radiofrequency fields
- Left-handed
- Individuals with chronic inflammation (e.g. severe arthritis, psoriasis, inflammatory bowel disease, asthma, polyneuropathies, Lupus)
- Intent to move or take an extended vacation (i.e. longer than 1 month during the study period)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beckman Institute, University of Illinois
Champaign, Illinois, 61801
University of Illinois
Urbana, Illinois, 61801
About this study
The purpose of this study is to examine the effect of aerobic fitness training on human cognition, brain structure, and brain function of older adults.
Read the detailed description
Recent studies have shown the encouraging effects of fitness training on human cognition, and brain structure and function. Such effects are of great interest both for what may they tell us about the nature of cognitive and brain aging and also for their public health implications. This study will test the hypotheses that: 1) improvements in aerobic fitness of older adults will lead to improved performance on a variety of cognitive processes, and especially those processes that are supported by frontal regions of the brain; 2) improvements in cognitive processes due to enhanced aerobic fitness will be visible on fMRI scans, and will be similar to those of young adults; 3) improvements in aerobic fitness, over the course of a 1 year intervention, will result in increases in gray and white matter volume.
One hundred forty sedentary older adults will be recruited for this study. Participants will be randomized to an aerobic exercise intervention group, or to a stretching and toning control group. Aerobic exercise sessions will be conducted three times a week for one year, beginning at a light to moderate intensity level over the first two months and progressing to a moderate to high level for the remainder of the year. The control group will meet on the same basis as the intervention group, and will participate in an organized program of stretching, limbering, and toning for the whole body that is specially designed for individuals 60 years of age and older.
During this time, participants will exercise, keep a daily exercise log detailing distance walked (routes will be measured and mapped for participants), time spent in aerobic activity, degree of intensity (rating of perceived exertion), general level of affect during exercise, resting and exercise heart rates. Participants will participate in the MRI/fMRI, physiological (cardiorespiratory) and psychosocial testing prior to the beginning of the fitness training intervention, following 6 months of fitness training, and at the conclusion of the 1 year of fitness training.
- Conditions
- Aging, Cognitive Ability, General
- Being tested
- Aerobic Exercise, Stretching and toning
- Keywords
- Mild Cognitive Impairment, cognition disorders, brain health, psychological aspect of aging, exercise, physical fitness
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
One hour per day three times a week for one year
Stretching and toningBehavioural
One hour per day three times a week for one year
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Intervention Group- aerobic exercise Receives: Behavioral: Aerobic Exercise | |
| group 2 | Control Group- stretching and toning Receives: Behavioral: Stretching and toning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measures
Measured: baseline, 6 and 12 months
Secondary outcomes (1)
fMRI
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Arthur Kramer, University of Illinois at Urbana-Champaign
- Investigators
- Art Kramer, PhD, Principal investigator, Beckman Institute, University of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438347
- Sponsor's protocol ID
- IA0102
- Other IDs
- 5R37AG025667-02
- Status last verified
- Nov 2016
- First submitted
- 21 Feb 2007
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Colcombe SJ, Kramer AF, Erickson KI, Scalf P, McAuley E, Cohen NJ, Webb A, Jerome GJ, Marquez DX, Elavsky S. Cardiovascular fitness, cortical plasticity, and aging. Proc Natl Acad Sci U S A. 2004 Mar 2;101(9):3316-21. doi: 10.1073/pnas.0400266101. Epub 2004 Feb 20.
PubMed 14978288Barnes DE, Yaffe K, Satariano WA, Tager IB. A longitudinal study of cardiorespiratory fitness and cognitive function in healthy older adults. J Am Geriatr Soc. 2003 Apr;51(4):459-65. doi: 10.1046/j.1532-5415.2003.51153.x.
PubMed 12657064Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
PubMed 12661673Colcombe SJ, Erickson KI, Raz N, Webb AG, Cohen NJ, McAuley E, Kramer AF. Aerobic fitness reduces brain tissue loss in aging humans. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):176-80. doi: 10.1093/gerona/58.2.m176.
PubMed 12586857Fanning J, Porter G, Awick EA, Ehlers DK, Roberts SA, Cooke G, Burzynska AZ, Voss MW, Kramer AF, McAuley E. Replacing sedentary time with sleep, light, or moderate-to-vigorous physical activity: effects on self-regulation and executive functioning. J Behav Med. 2017 Apr;40(2):332-342. doi: 10.1007/s10865-016-9788-9. Epub 2016 Sep 1.
PubMed 27586134Nagamatsu LS, Weinstein AM, Erickson KI, Fanning J, Awick EA, Kramer AF, McAuley E. Exercise Mode Moderates the Relationship Between Mobility and Basal Ganglia Volume in Healthy Older Adults. J Am Geriatr Soc. 2016 Jan;64(1):102-8. doi: 10.1111/jgs.13882.
PubMed 26782858Gothe NP, Fanning J, Awick E, Chung D, Wojcicki TR, Olson EA, Mullen SP, Voss M, Erickson KI, Kramer AF, McAuley E. Executive function processes predict mobility outcomes in older adults. J Am Geriatr Soc. 2014 Feb;62(2):285-90. doi: 10.1111/jgs.12654. Epub 2014 Jan 21.
PubMed 24521364Mullen SP, Wojcicki TR, Mailey EL, Szabo AN, Gothe NP, Olson EA, Fanning J, Kramer A, McAuley E. A profile for predicting attrition from exercise in older adults. Prev Sci. 2013 Oct;14(5):489-96. doi: 10.1007/s11121-012-0325-y.
PubMed 23412942Wojcicki TR, Szabo AN, White SM, Mailey EL, Kramer AF, McAuley E. The perceived importance of physical activity: associations with psychosocial and health-related outcomes. J Phys Act Health. 2013 Mar;10(3):343-9. doi: 10.1123/jpah.10.3.343. Epub 2012 Jun 14.
PubMed 22820124Mullen SP, Olson EA, Phillips SM, Szabo AN, Wojcicki TR, Mailey EL, Gothe NP, Fanning JT, Kramer AF, McAuley E. Measuring enjoyment of physical activity in older adults: invariance of the physical activity enjoyment scale (paces) across groups and time. Int J Behav Nutr Phys Act. 2011 Sep 27;8:103. doi: 10.1186/1479-5868-8-103.
PubMed 21951520McAuley E, Mullen SP, Szabo AN, White SM, Wojcicki TR, Mailey EL, Gothe NP, Olson EA, Voss M, Erickson K, Prakash R, Kramer AF. Self-regulatory processes and exercise adherence in older adults: executive function and self-efficacy effects. Am J Prev Med. 2011 Sep;41(3):284-90. doi: 10.1016/j.amepre.2011.04.014.
PubMed 21855742Szabo AN, Mullen SP, White SM, Wojcicki TR, Mailey EL, Gothe N, Olson EA, Fanning J, Kramer AF, McAuley E. Longitudinal invariance and construct validity of the abbreviated late-life function and disability instrument in healthy older adults. Arch Phys Med Rehabil. 2011 May;92(5):785-91. doi: 10.1016/j.apmr.2010.12.033. Epub 2011 Apr 1.
PubMed 21458777
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fitness on Brain and Cognition
- ClinicalTrials.gov ID
- NCT00438347
- Acronym / sponsor ID
- IA0102
- Conditions
- Aging, Cognitive Ability, General
- Keywords
- Mild Cognitive Impairment, cognition disorders, brain health, psychological aspect of aging, exercise, physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 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 examine the effect of aerobic fitness training on human cognition, brain structure, and brain function of older adults.
Detailed description
Recent studies have shown the encouraging effects of fitness training on human cognition, and brain structure and function. Such effects are of great interest both for what may they tell us about the nature of cognitive and brain aging and also for their public health implications. This study will test the hypotheses that: 1) improvements in aerobic fitness of older adults will lead to improved performance on a variety of cognitive processes, and especially those processes that are supported by frontal regions of the brain; 2) improvements in cognitive processes due to enhanced aerobic fitness will be visible on fMRI scans, and will be similar to those of young adults; 3) improvements in aerobic fitness, over the course of a 1 year intervention, will result in increases in gray and white matter volume.
One hundred forty sedentary older adults will be recruited for this study. Participants will be randomized to an aerobic exercise intervention group, or to a stretching and toning control group. Aerobic exercise sessions will be conducted three times a week for one year, beginning at a light to moderate intensity level over the first two months and progressing to a moderate to high level for the remainder of the year. The control group will meet on the same basis as the intervention group, and will participate in an organized program of stretching, limbering, and toning for the whole body that is specially designed for individuals 60 years of age and older.
During this time, participants will exercise, keep a daily exercise log detailing distance walked (routes will be measured and mapped for participants), time spent in aerobic activity, degree of intensity (rating of perceived exertion), general level of affect during exercise, resting and exercise heart rates. Participants will participate in the MRI/fMRI, physiological (cardiorespiratory) and psychosocial testing prior to the beginning of the fitness training intervention, following 6 months of fitness training, and at the conclusion of the 1 year of fitness training.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Behavioral: Aerobic ExerciseIntervention Group- aerobic exercise |
| group 2 | – | Behavioral: Stretching and toningControl Group- stretching and toning |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults over 60
Key inclusion criteria (8 listed)
- 60 to 75 years of age (for Sedentary Older Adults)
- Sedentary Older Adults: no physical activity in last six months; Young Comparison Sample: Moderately active lifestyle
- 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 (7 listed)
- Sedentary Older Adults: self reported physical activity on regular basis (2 times or more per week) in last six months; Young Comparison Sample: sedentary or highly active/athletic lifestyle
- Any physical disability that prohibits mobility (walking), stretching etc.
- Depression score on GDS indicative of clinical depression
- Presence of any implanted devices such as cardiac pacemakers or autodefibrillators; neural pacemakers, aneurysm clips in the CNS; cochlear implants; metallic bodies in the eye or CNS; any form of wires or metal devices that concentrate radiofrequency fields
- Left-handed
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 |
|---|---|---|
| Aerobic ExerciseOne hour per day three times a week for one year | Behavioural | group 1 |
| Stretching and toningOne hour per day three times a week for one year | Behavioural | group 2 |
Primary outcome
Behavioral measures
Time frame: baseline, 6 and 12 months
1 secondary outcome
fMRI
Time frame: baseline, 6 and 12 months
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 8 Nov 2016.
- Background: PubMed 14978288Colcombe SJ, Kramer AF, Erickson KI, Scalf P, McAuley E, Cohen NJ, Webb A, Jerome GJ, Marquez DX, Elavsky S. Cardiovascular fitness, cortical plasticity, and aging. Proc Natl Acad Sci U S A. 2004 Mar 2;101(9):3316-21. doi: 10.1073/pnas.0400266101. Epub 2004 Feb 20.
- Background: PubMed 12657064Barnes DE, Yaffe K, Satariano WA, Tager IB. A longitudinal study of cardiorespiratory fitness and cognitive function in healthy older adults. J Am Geriatr Soc. 2003 Apr;51(4):459-65. doi: 10.1046/j.1532-5415.2003.51153.x.
- Background: PubMed 12661673Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
- Background: PubMed 12586857Colcombe SJ, Erickson KI, Raz N, Webb AG, Cohen NJ, McAuley E, Kramer AF. Aerobic fitness reduces brain tissue loss in aging humans. J Gerontol A Biol Sci Med Sci. 2003 Feb;58(2):176-80. doi: 10.1093/gerona/58.2.m176.
- Derived from this study: PubMed 27586134Fanning J, Porter G, Awick EA, Ehlers DK, Roberts SA, Cooke G, Burzynska AZ, Voss MW, Kramer AF, McAuley E. Replacing sedentary time with sleep, light, or moderate-to-vigorous physical activity: effects on self-regulation and executive functioning. J Behav Med. 2017 Apr;40(2):332-342. doi: 10.1007/s10865-016-9788-9. Epub 2016 Sep 1.
- Derived from this study: PubMed 26782858Nagamatsu LS, Weinstein AM, Erickson KI, Fanning J, Awick EA, Kramer AF, McAuley E. Exercise Mode Moderates the Relationship Between Mobility and Basal Ganglia Volume in Healthy Older Adults. J Am Geriatr Soc. 2016 Jan;64(1):102-8. doi: 10.1111/jgs.13882.
- Derived from this study: PubMed 24521364Gothe NP, Fanning J, Awick E, Chung D, Wojcicki TR, Olson EA, Mullen SP, Voss M, Erickson KI, Kramer AF, McAuley E. Executive function processes predict mobility outcomes in older adults. J Am Geriatr Soc. 2014 Feb;62(2):285-90. doi: 10.1111/jgs.12654. Epub 2014 Jan 21.
- Derived from this study: PubMed 23412942Mullen SP, Wojcicki TR, Mailey EL, Szabo AN, Gothe NP, Olson EA, Fanning J, Kramer A, McAuley E. A profile for predicting attrition from exercise in older adults. Prev Sci. 2013 Oct;14(5):489-96. doi: 10.1007/s11121-012-0325-y.
- Derived from this study: PubMed 22820124Wojcicki TR, Szabo AN, White SM, Mailey EL, Kramer AF, McAuley E. The perceived importance of physical activity: associations with psychosocial and health-related outcomes. J Phys Act Health. 2013 Mar;10(3):343-9. doi: 10.1123/jpah.10.3.343. Epub 2012 Jun 14.
- Derived from this study: PubMed 21951520Mullen SP, Olson EA, Phillips SM, Szabo AN, Wojcicki TR, Mailey EL, Gothe NP, Fanning JT, Kramer AF, McAuley E. Measuring enjoyment of physical activity in older adults: invariance of the physical activity enjoyment scale (paces) across groups and time. Int J Behav Nutr Phys Act. 2011 Sep 27;8:103. doi: 10.1186/1479-5868-8-103.
- Derived from this study: PubMed 21855742McAuley E, Mullen SP, Szabo AN, White SM, Wojcicki TR, Mailey EL, Gothe NP, Olson EA, Voss M, Erickson K, Prakash R, Kramer AF. Self-regulatory processes and exercise adherence in older adults: executive function and self-efficacy effects. Am J Prev Med. 2011 Sep;41(3):284-90. doi: 10.1016/j.amepre.2011.04.014.
- Derived from this study: PubMed 21458777Szabo AN, Mullen SP, White SM, Wojcicki TR, Mailey EL, Gothe N, Olson EA, Fanning J, Kramer AF, McAuley E. Longitudinal invariance and construct validity of the abbreviated late-life function and disability instrument in healthy older adults. Arch Phys Med Rehabil. 2011 May;92(5):785-91. doi: 10.1016/j.apmr.2010.12.033. Epub 2011 Apr 1.
- Individual participant dataSharing planned: No
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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.
Art Kramer, PhD principal investigator
Beckman Institute, University of Illinois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Cognitive Ability, General, run by University of Illinois at Urbana-Champaign at 2 sites 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 8 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Behavioral measures (time frame: baseline, 6 and 12 months). 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 NCT00438347, which also lists 12 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 8 Nov 2016.