Cognitive Effects of Aerobic Exercise for MCI Adults

NCT00220467 | Completed Phase 2

• 2 other identifiers: RDIS 0008ALZ ASSOC BL18 (SIBCR)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Keywords

MCI; aging; cognition; exercise; aerobic; insulin

Outcome Measures

Primary Outcomes (2)

• Change in cognitive scores

• Change in insulin sensitivity

Secondary Outcomes (2)

• Change in biomarkers associated with Alzheimer's disease progression

• Correlation between cognitive scores, insulin sensitivity, & biomarkers

Interventions

Aerobic exercise BEHAVIORAL

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Alzheimer's Association: collaborator

Study Sites (2)

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Veterans Affairs Puget Sound Health Care System

Tacoma, Washington, 98493, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura D Baker, PhD

  VA Puget Sound Health Care System; University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

US (2)