The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative exercise program called Preventing Loss of Independence through Exercise (PLI) on function and quality of life in older Veterans living in the community with dementia. Dementia is a devastating condition that affects nearly 1 in 10 older veterans (~1 million individuals). Current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course; however, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia. PLI was developed based on recent discoveries in neuroscience and experimental psychology that have found that, although explicit memory (the ability to consciously recall new information) is impaired in individuals with dementia, implicit memory (unconscious learning that typically occurs through repeated exposure) is relatively preserved. Therefore, PLI focuses on training procedural memory (unconscious learning of procedures) to build the strength and capacity to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing). In addition, to maximize the benefits of the training, PLI integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection. We have recently completed a pilot study of the PLI program at an adult day health center in San Francisco, CA, finding that it was associated with clinically meaningful improvements in cognitive function, physical performance and quality of life as well as reduced caregiver burden when compared with usual care at the facility. The proposed study will enable us to build on these exciting pilot study results by performing a full-scale RCT at adult day health centers in Northern California. Most VA Medical Centers currently contract with community-based organizations to provide adult day health care to eligible Veterans with dementia. Therefore, sites for the current study will be adult day health centers that have current contracts with either the San Francisco VA (SFVA) or Palo Alto VA (PAVA). Within each center, study participants will be randomly assigned to receive the PLI intervention program (45 minutes, 2 days/week, 6 months) or Usual Care (UC) control (standard center activities, 45 minutes, 2 days/week, 6 months) (N=144, 72/group). Our co-primary outcomes will be 6-month change in cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog), independence (Functional Independence Measure, FIM) and quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Changes in caregiver burden (Caregiver Burden Inventory, CBI) will be examined as a secondary outcome. We also propose to determine whether the effects of PLI are maintained over 6 months after the intervention period; thus, all outcomes will be assessed at baseline, 6 months and 12 months. The proposed project will address a critically important Veterans' health problem related to optimizing functional status and quality of life in older Veterans with dementia. It is directly responsive to Request for Applications (RFA) RX-14-011 (RR&D Merit Review Award for Research on Amyotrophic Lateral Sclerosis, Parkinson's Disease and Alzheimer's Disease), which has identified pioneering new and innovative rehabilitation methodologies to restore function and improve quality of life for Veterans living with [these] neurodegenerative diseases as a major focus. Many patients and caregivers currently feel that little is being done to help individuals with dementia maintain function and quality of life. Our proposed study will utilize rigorous research methods to test the efficacy of a highly innovative and promising new program for older adults with dementia. If our program is successful, we will work with VA and community-based organization to implement PLI more broadly.

Public Health Relevance

Nearly 1 in 10 older Veterans have dementia, which is a devastating condition that leads to a progressive loss of independence and functional status. Currently available dementia medications do not alter the disease course. Therefore, it is critically important to identify effective strategies for helping older Veterans living with dementia to enhance their functional status and quality of life. We have developed a novel, integrative exercise program called Preventing Loss of Independence through Exercise (PLI) that incorporates elements from Eastern and Western exercise modalities and is designed to build and maintain the capacity to perform basic functional movements while increasing mindful body awareness and enhancing social connection. Our pilot study results suggest that PLI is associated with meaningful improvements in physical function, cognitive function and quality of life as well as reduced caregiver burden. The goal of the proposed study is to perform a full-scale randomized, controlled trial to test the efficacy of PLI in older Veterans with dementia.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01RX001507-03
Application #
9179554
Study Section
Psychological Health & Social Reintegration (RRD4)
Project Start
2015-01-01
Project End
2018-12-31
Budget Start
2017-01-01
Budget End
2017-12-31
Support Year
3
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Veterans Affairs Medical Center San Francisco
Department
Type
DUNS #
078763885
City
San Francisco
State
CA
Country
United States
Zip Code
94121
Ventura, Maria I; Barnes, Deborah E; Ross, Jessica M et al. (2016) A pilot study to evaluate multi-dimensional effects of dance for people with Parkinson's disease. Contemp Clin Trials 51:50-55