Telemedicine Intervention to Improve Cognitive Function

VA Office of Research and Development

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Health education; Behavioral: Structured physical activity

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02248649

N1696-I

Details and patient eligibility

About

This project is investigating whether a home-based exercise program will reduce cognitive decline in patients with Parkinson's disease.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Physical Activity

Experimental group

Description:

Structured walking program

Treatment:

Behavioral: Structured physical activity

Control

Active Comparator group

Description:

Health education attention control

Treatment:

Behavioral: Health education