Feasibility And Impact Of Studying Aerobic Exercise In Alzheimer's Disease

Fang Yu, PhD
University of Minnesota (Minneapolis, MN)

Co-Principal Investigators

Maurice Dysken, MD
Minneapolis VA Medical Center
Patricia Painter, PhD
University of Minnesota
Jean Wyman, PhD
University of Minnesota
Year Awarded:
2009
Grant Duration:
April 1, 2009 to March 31, 2011
Disease:
Alzheimer's Disease
Award Amount:
$150,000
Grant Reference ID:
A2009344
Award Type:
Pilot
Award Region:
US Midwestern
Fang Yu, PhD

Feasibility Of Aerobic Exercise In Alzheimer's Disease

Summary

Aerobic exercise training is a promising intervention that does not rely on drugs for slowing the progression of Alzheimer's disease (AD) symptoms such as cognitive impairment, decline in activities of daily living, and behavioral and psychological symptoms of dementia. Our study will determine the feasibility of recruiting and retaining 30 community-dwelling persons with AD to participate in a 6-month, individualized, moderate-intensity aerobic exercise program (cycling on recumbent stationary cycles) at community gyms. This study is expected to provide data to design and implement future randomized controlled trials to test the effects of aerobic exercise training in AD and will facilitate the development of aerobic exercise prescription guidelines in AD.

Details

Uniqueness of our research aims:
The increasing burdens of assisting with the activities of daily living (ADL) and managing dementia behaviors are often the tipping point for community-dwelling persons with Alzheimer's disease (AD) to become institutionalized, although institutionalization is often the catalyze toward a downward spiral of one's quality of life. Aerobic exercise training is a promising treatment in AD because exercise training improves brain and cognitive function, weakens AD neuropathology, and reduces ADL decline and dementia behaviors. Findings from our research will help to determine the effects of aerobic exercise training on cognition and physical function in persons with AD, to apply these findings to develop aerobic exercise prescription guidelines for persons with AD, and ultimately to slow AD progression.

This study's objective is to determine the feasibility of recruiting and retaining 30 community-dwelling persons with AD to participate in 6-month, individualized, moderate-intensity cycling on recumbent stationary cycles at community gyms with three aims:

Aim I: Determine recruitment feasibility, retention rate, and exercise adherence for 6-month cycling program in 30 community-dwelling persons with mild to moderate AD.
1. Can we enroll and train greater than or equal to 80% of the 30 qualified participants within two years?

Aim II: Evaluate patterns of change over 6 months in participants' global cognition, executive functioning, physical function, ADL, and the Behavioral Psychological Symptoms of Dementia (BPSD) assessment.
1. Can greater than or equal to 80% of the participants complete all 3- and 6-month measurements to allow evaluation of patterns of change in stated outcomes?

Aim III: Estimate change in participants' global cognition to help determine sample size for a randomized controlled trial (RCT).
1. Can all participants complete all 3 testing for global cognition by the end of year 2?

Research Updates

The objective of this pilot study is to determine the feasibility of recruiting and retaining 30 community-dwelling persons with Alzheimer's disease in a 6-month, moderate-intensity, 3-times-a-week aerobic exercise. During this report period, we obtained approval from the Institutional Review Board (IRB) on June 23, 2009. An unexpected complication arose, however, during the planning meeting with the local gym owner who required our subjects to sign a Waiver form. The Waiver was reviewed by the university legal team and certain clauses were deemed exculpatory. As a result, the IRB required the exercise training to be conducted only in a university facility on September 17, 2009. Subsequently, the study's Principal Investigator worked with the legal team to revise the protocol. Subjects will be required to show proof of a health club/gym membership before their formal acceptance. If subjects do not have a gym affiliation, they can receive exercise training in one of our four established sites in non-profit organizations. Ten recruitment methods were developed in different stages of implementation, including: partnership with local organizations; community events; physician cooperation; study invitation letters for patients with a diagnosis of Alzheimer's disease; press releases; newspaper advertisements; flyers at Alzheimer's disease support groups and adult day care centers; senior residences; state fairs; and Web sites. As of December 31, 2009, 28 inquiries from patients with Alzheimer's disease and their family members have been received. Phone screening has been conducted with 7 informants, and one subject has consented and been screened in person.
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