Clinical trial NCT00220467: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Keywords: MCI
aging
cognition
exercise
aerobic
insulin
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cognitive scores
measure: Change in insulin sensitivity
Secondary outcomes:
measure: Change in biomarkers associated with Alzheimer's disease progression
measure: Correlation between cognitive scores, insulin sensitivity, & biomarkers
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
city: Tacoma
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System; University of Washington
name: Laura D Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: