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Cognitive Effects of Aerobic Exercise for MCI Adults

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring MCI, aging, cognition, exercise, aerobic, insulin

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: diagnosed with mild cognitive impairment, at least 55 years of age, sedentary (elevated HR & SOB <3x/wk and <30min on each occasion), overall good general health, willing to exercise at least 4 times/wk for 6 months Exclusion Criteria: Significant neurologic disease that might affect cognition, such as a diagnosis of Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness; significant medical illness or organ failure such as liver disease, significant elevations in liver function tests, kidney disease, uncontrolled hypertension (BP>140/90 on medication); cardiovascular disease defined as any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema; chronic lung disease, or musculoskeletal impairment (impaired walking); current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative, or any cognition-enhancing medications; current or previous use of hypoglycemic agents or insulin.

Sites / Locations

  • Veterans Affairs Puget Sound Health Care System
  • Veterans Affairs Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Change in cognitive scores
Change in insulin sensitivity

Secondary Outcome Measures

Change in biomarkers associated with Alzheimer's disease progression
Correlation between cognitive scores, insulin sensitivity, & biomarkers

Full Information

First Posted
September 21, 2005
Last Updated
July 29, 2008
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT00220467
Brief Title
Cognitive Effects of Aerobic Exercise for MCI Adults
Official Title
Cognitive Effects of Aerobic Exercise for Adults With Mild Cognitive Impairment: A Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
Alzheimer's Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.
Detailed Description
The specific aims for the study are 1) to determine if aerobic exercise enhances cognition for older adults with mild cognitive impairment, 2) to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects in the aerobic exercise group, and 3) to relate exercise effects on insulin sensitivity and cognition to growth factor expression, inflammatory markers, catecholamines, beta-amyloid, and body-fat composition. Using a randomized controlled parallel group design, 40 sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity (via hyperinsulinemic-euglycemic clamp), maximum aerobic capacity (via respiratory gas exchange and cardiopulmonary fitness measures), and body fat composition (via DEXA scan) and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
MCI, aging, cognition, exercise, aerobic, insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Primary Outcome Measure Information:
Title
Change in cognitive scores
Title
Change in insulin sensitivity
Secondary Outcome Measure Information:
Title
Change in biomarkers associated with Alzheimer's disease progression
Title
Correlation between cognitive scores, insulin sensitivity, & biomarkers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosed with mild cognitive impairment, at least 55 years of age, sedentary (elevated HR & SOB <3x/wk and <30min on each occasion), overall good general health, willing to exercise at least 4 times/wk for 6 months Exclusion Criteria: Significant neurologic disease that might affect cognition, such as a diagnosis of Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness; significant medical illness or organ failure such as liver disease, significant elevations in liver function tests, kidney disease, uncontrolled hypertension (BP>140/90 on medication); cardiovascular disease defined as any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema; chronic lung disease, or musculoskeletal impairment (impaired walking); current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative, or any cognition-enhancing medications; current or previous use of hypoglycemic agents or insulin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura D Baker, PhD
Organizational Affiliation
VA Puget Sound Health Care System; University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Veterans Affairs Puget Sound Health Care System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

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Cognitive Effects of Aerobic Exercise for MCI Adults

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