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

September 17, 2013 updated by: The Cleveland Clinic

Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain activation patterns measured by functional MRI
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological Testing
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Exercise assessment
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Stephen M Rao, Ph.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH AG035775-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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