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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438347
Other study ID # IA0102
Secondary ID 5R37AG025667-02
Status Completed
Phase N/A
First received February 21, 2007
Last updated November 4, 2016
Start date April 2006
Est. completion date May 2012

Study information

Verified date November 2016
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 179
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic Exercise
One hour per day three times a week for one year
Stretching and toning
One hour per day three times a week for one year

Locations

Country Name City State
United States Beckman Institute, University of Illinois Champaign Illinois
United States University of Illinois Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barnes 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. — View Citation

Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. — View Citation

Colcombe 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral measures baseline, 6 and 12 months No
Secondary fMRI baseline, 6 and 12 months No
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