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Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01038726
First received: December 21, 2009
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.


Condition Intervention
Aging
Alzheimer's Disease
 Other: Exercise Training
Other: Cognitive Training
Other: Flexibility Training
Other: Educational Sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Brain activation patterns measured by functional MRI [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychological Testing [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Exercise assessment [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Training Other: Exercise Training
Aerobic exercise training program designed by the Cardiac Rehabilitation department
Active Comparator: Combined Cognitive/Exercise Training Other: Exercise Training
Aerobic exercise training program designed by the Cardiac Rehabilitation department
Other: Cognitive Training
Based on cognitive training program Brain Fitness®
Active Comparator: Cognitive Training Other: Cognitive Training
Based on cognitive training program Brain Fitness®
Active Comparator: Combined Low Intensity Training Other: Flexibility Training
Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department
Other: Educational Sessions
DVD-based educational programs on history, art, and literature

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First or Second-degree relative of someone with Alzheimer's Disease
  • Not currently engaging in regular exercise
  • Able to undergo an MRI
  • Fluent in English

Exclusion Criteria:

  • Neurological illnesses/conditions
  • Medical illness/conditions that may affect brain function
  • Any unstable or severe cardiovascular disease or asthmatic condition
  • Severe depressive symptoms
  • Inability to walk unassisted
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038726

Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Institutes of Health (NIH)
Investigators
Principal Investigator: Stephen M Rao, Ph.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01038726     History of Changes
Other Study ID Numbers: NIH AG035775-01
Study First Received: December 21, 2009
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Healthy Aging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013