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IIR 11-342 – HSR&D Study

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IIR 11-342
A telemedicine intervention to improve physical function in patients with PD
David William Sparrow DSc
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, MA
Funding Period: October 2012 - September 2016

BACKGROUND/RATIONALE:
Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD are motoric, which limits functional mobility leading to difficulty working, caring for family members, or managing a household, and to overall decreased independence and quality of life (QOL). A growing wealth of data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established.

OBJECTIVE(S):
The overall goal of the proposed research was to evaluate the effectiveness of a home-based approach to providing the known benefits of a safe exercise program to people with PD. We hypothesized that a one-year exercise program, centered around remote, real-time instruction and supervision, would reduce the rate of falls and improve strength and QOL in patients with PD.

METHODS:
The project was a randomized, controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. One hundred sixty-nine patients (mean age, 72 years), who met entry criteria (physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD [tremor, rigidity, bradykinesia], and response to dopaminergic medication defined as a functional improvement in at least one of the cardinal symptoms) were randomly assigned to receive structured and remote exercise instruction and supervision in real-time, or receive an educational healthy lifestyle program. In the structured program, patients performed stretches, balance exercises, and strengthening exercises. In the lifestyle program, patients received recommendations for exercise based on the National Parkinson Foundation's Fitness Counts program, as well as additional information in the following content areas: medical conditions, common symptoms, and preventative medicine. The interventions lasted one year.

FINDINGS/RESULTS:
Our primary outcome was the 1-year fall rate. We used a negative binomial model, which allows expression of the rate of falls in the two groups (structured exercise program, educational healthy lifestyle program) as an incidence rate ratio (IRR). The structured exercise program significantly reduced fall rate over the 1-year trial (p < 0.001). The estimated IRR was 0.39 (95% CI, 0.22 to 0.68) indicating a 39% reduction in fall rate.

The secondary outcomes, lower-extremity muscle strength (sit-to-stand test) and quality of life (39-item Parkinson's Disease Questionnaire [PDQ-39]), are both continuous measures. We used PROC MIXED (SAS) to estimate effects based on a mixed-effects longitudinal model (Diggle PJ et al. Analysis of Longitudinal Data. NY: Oxford University Press Inc.; 1994). The unstructured covariance model was used to allow for different variances at each time point (baseline, 6 months, 12 months) and different correlations between outcomes for each pair of visits. The structured exercise program significantly improved sit-to-stand time between baseline and 6 months, as compared with the education program (coefficient = -3.5, p = 0.02) and was of borderline significance in improving sit-to-stand time between baseline and 12 months (coefficient = -2.28, p = 0.12). Exercise effects on the PDQ-39 at 6 months and 12 months were not statistically significant though the coefficients were in the expected direction.

IMPACT:
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting over 40,000 veterans currently being treated within the VA Healthcare System, a number that is likely to increase in the future. Over the last decade, more evidence has emerged revealing significant and clinically meaningful benefits of exercise for persons with PD. However, such exercise programs are typically conducted in VA hospital settings or community-based facilities, which can place travel, financial, and time burdens on participants. This is especially burdensome on patients with PD, a large proportion of whom often have limited functional mobility. Our findings demonstrated that a structured home-based exercise program, delivered with remote supervision, improved PD outcomes. Specifically, patients had a significant reduction in fall rate and overall improvement in lower-extremity strength. This intervention has the dual advantage of low cost and relatively easy dissemination and can be incorporated into the care of patients with PD throughout the VA system, in turn, enhancing access to treatment and optimizing care.

PUBLICATIONS:
None at this time.


DRA: Aging, Older Veterans' Health and Care, Neurodegenerative Diseases
DRE: Treatment - Comparative Effectiveness
Keywords: none
MeSH Terms: none

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