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Influence of Fitness on Brain and Cognition

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), August 2008

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00438347
  Purpose

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.


Condition Intervention
Aging
Cognition
Behavioral: Aerobic Exercise
Behavioral: Stretching and toning

MedlinePlus related topics:   Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Influence of Fitness on Brain and Cognition

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Behavioral measures [ Time Frame: baseline, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fMRI [ Time Frame: baseline, 6 and 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   140
Study Start Date:   April 2006
Estimated Study Completion Date:   November 2009

Groups/Cohorts Assigned Interventions
1
Intervention Group
Behavioral: Aerobic Exercise
One hour per day three times a week for one year
2
Control Group
Behavioral: Stretching and toning
One hour per day three times a week for one year

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.

  Eligibility
Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Healthy adults over 60


Criteria

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438347

Contacts
Contact: Art Kramer, PhD     217-244-1933     akramer@cyrus.psych.uiuc.edu    

Locations
United States, Illinois
Beckman Institute, University of Illinois     Recruiting
      Champaign, Illinois, United States, 61801
      Principal Investigator: Art Kramer, PhD            
      Sub-Investigator: Neal Cohen, PhD            
      Sub-Investigator: Stanley Colcombe, PhD            
      Sub-Investigator: Edward McAuley, PhD            
      Sub-Investigator: Bradley Sutton, PhD            
      Sub-Investigator: Jeffery Woods, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Art Kramer, PhD     Beckman Institute, University of Illinois    
  More Information

Publications:

Responsible Party:   Beckman Institute, University of Illinois ( Art Kramer, PhD )
Study ID Numbers:   IA0102, 5R37AG025667-02
First Received:   February 21, 2007
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00438347
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Mild Cognitive Impairment  
cognition disorders  
brain health  
psychological aspect of aging
exercise
physical fitness

Study placed in the following topic categories:
Cognition Disorders

ClinicalTrials.gov processed this record on September 04, 2008




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