NCT00438347

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

6.1 years

First QC Date

February 21, 2007

Last Update Submit

November 4, 2016

Conditions

AgingCognitive Ability, General

Keywords

Mild Cognitive Impairmentcognition disordersbrain healthpsychological aspect of agingexercisephysical fitness

Outcome Measures

Primary Outcomes (1)

  • Behavioral measures

    baseline, 6 and 12 months

Secondary Outcomes (1)

  • fMRI

    baseline, 6 and 12 months

Study Arms (2)

group 1

Intervention Group- aerobic exercise

Behavioral: Aerobic Exercise

group 2

Control Group- stretching and toning

Behavioral: Stretching and toning

Interventions

Aerobic ExerciseBEHAVIORAL

One hour per day three times a week for one year

group 1
Stretching and toningBEHAVIORAL

One hour per day three times a week for one year

group 2

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults over 60

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Institute, University of Illinois

Champaign, Illinois, 61801, United States

Location

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (12)

  • 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.

    PMID: 14978288BACKGROUND

  • 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. doi: 10.1046/j.1532-5415.2003.51153.x.

    PMID: 12657064BACKGROUND

  • 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. doi: 10.1111/1467-9280.t01-1-01430.

    PMID: 12661673BACKGROUND

  • 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. doi: 10.1093/gerona/58.2.m176.

    PMID: 12586857BACKGROUND

  • Fanning 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.

    PMID: 27586134DERIVED

  • Nagamatsu 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.

    PMID: 26782858DERIVED

  • Gothe 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.

    PMID: 24521364DERIVED

  • Mullen 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.

    PMID: 23412942DERIVED

  • Wojcicki 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.

    PMID: 22820124DERIVED

  • Mullen 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.

    PMID: 21951520DERIVED

  • McAuley 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.

    PMID: 21855742DERIVED

  • Szabo 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.

    PMID: 21458777DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionCognition DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Art Kramer, PhD

    Beckman Institute, University of Illinois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Beckman Institute

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

April 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)