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

Primary Purpose

Aging, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Cognitive Training
Flexibility Training
Educational Sessions
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Healthy Aging

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exercise Training

Combined Cognitive/Exercise Training

Cognitive Training

Combined Low Intensity Training

Arm Description

Outcomes

Primary Outcome Measures

Brain activation patterns measured by functional MRI

Secondary Outcome Measures

Neuropsychological Testing
Exercise assessment

Full Information

First Posted
December 21, 2009
Last Updated
September 17, 2013
Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01038726
Brief Title
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults
Official Title
Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Alzheimer's Disease
Keywords
Healthy Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Active Comparator
Arm Title
Combined Cognitive/Exercise Training
Arm Type
Active Comparator
Arm Title
Cognitive Training
Arm Type
Active Comparator
Arm Title
Combined Low Intensity Training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
Aerobic exercise training program designed by the Cardiac Rehabilitation department
Intervention Type
Other
Intervention Name(s)
Cognitive Training
Intervention Description
Based on cognitive training program Brain Fitness®
Intervention Type
Other
Intervention Name(s)
Flexibility Training
Intervention Description
Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department
Intervention Type
Other
Intervention Name(s)
Educational Sessions
Intervention Description
DVD-based educational programs on history, art, and literature
Primary Outcome Measure Information:
Title
Brain activation patterns measured by functional MRI
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Neuropsychological Testing
Time Frame
baseline and 12 weeks
Title
Exercise assessment
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Rao, Ph.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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