A Telemedicine Intervention to Improve Cognitive Function in Patients With PD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- VA Office of Research and Development
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.
Detailed Description
Background/Rationale: Progressive cognitive impairment leading to dementia is an important component of Parkinson's disease (PD), contributing to significant levels of disability. The number of Veterans who will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely to increase substantially. Given the profound negative health and social consequences associated with the development of dementia, it is critical to identify interventions that effectively slow the decline of cognitive function to prolong the time to onset of dementia. Based on the results of prior studies, physical activity is one of the few nonpharmacological interventions that holds promise in slowing cognitive decline. Objective: The investigators hypothesize that a home-based physical activity intervention to promote walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD (PD-MCI). Methods: The proposed study is a randomized, controlled trial of a home-based walking intervention, evaluating effects on cognitive function. Community-dwelling Veterans with PD-MCI will be randomized to a walking intervention or a health education control intervention. Subjects will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and MCI. The interventions will last 18 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- •At least 2 of 3 cardinal signs of PD
- •Response to dopaminergic medication
- •Mild cognitive impairment
Exclusion Criteria
- •Angina pectoris
- •History of myocardial infarction within 6 months
- •History of ventricular dysrhythmia requiring current therapy
Outcomes
Primary Outcomes
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
Time Frame: Baseline and 6 months
The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.
Secondary Outcomes
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12(Baseline and 12 months)
- Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18(Baseline and 18 month)