Genes, Exercise, Memory and Neurodegeneration

Effects of Standardized Aerobic Exercise-Training on Neurocognitive and Neurodegeneration

Sponsors

Lead Sponsor: Howard University

Source Howard University
Brief Summary

The primary purpose of this pilot study is to determine whether African Americans with mild Alzheimer's disease (AD) can be enrolled and retained in a 6-month aerobic exercise-training study.

Detailed Description

This study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. It is yet to be determined whether African Americans with mild AD can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. In addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of APOE to aerobic fitness-induced changes in neurocognition. The long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (HDL-C), elevated inflammation (C-reactive protein (CRP) and interleukins (IL-1A)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase AD risk. Because many of these putative AD risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in AD risk.

Overall Status Completed
Start Date October 2009
Completion Date December 2013
Primary Completion Date December 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
AD Assessment Scale-Cognitive (ADAS-COG) baseline, 3 and 6 months
Secondary Outcome
Measure Time Frame
Mini-Mental State Exam (MMSE) baseline, 3 and 6 months
CDR (Clinical Dementia Rating) Scale baseline, 3 and 6 months
Logical Memory Test (Delayed Paragraph Recall) baseline and 6 months
Visuospatial and Visuographic: Clock Drawing Test baseline and 6 months
American National Adult Reading Test (ANART) baseline and 6 months
Neuropsychiatric Inventory Q (NPIQ) baseline and 6 months
Geriatric Depression Scale baseline and 6 months
Activities of Daily Living (ADCS-ADL) baseline and 6 months
PET imaging to measure cerebral glucose homeostasis/metabolism baseline and 6 months
Enrollment 73
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: aerobic exercise-training

Description: 3 times per week for 6 months

Arm Group Label: aerobic exercise-training

Intervention Type: Behavioral

Intervention Name: stretch exercise

Description: 3 times per week for 6 months

Arm Group Label: stretch exercise

Eligibility

Criteria:

Inclusion Criteria:

- Age over 60 years

- Ability to exercise vigorously without harm

- Mild AD

- Study partner

- In good general health

- Willing to exercise for 6 months

- Body Mass Index (BMI) less than 37

- Women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study

Exclusion Criteria:

- MMSE score below 20

- TG (Triglyceride) greater than 400 mg/dl

- LDL-C levels greater than 95% or HDL-C levels less than 10% of age and sex-adjusted norms

Gender: All

Minimum Age: 60 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thomas O. Obisesan, MD, MPH Principal Investigator Howard University
Location
Facility:
Howard University General Clinical Research Center (GCRC) | Washington, District of Columbia, 20060, United States
Temple University Exercise Physiology Laboratory | Philadelphia, Pennsylvania, 19140, United States
Location Countries

United States

Verification Date

February 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Howard University

Investigator Full Name: Thomas Obisesan

Investigator Title: Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: aerobic exercise-training

Type: Experimental

Label: stretch exercise

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov