Telemedicine Intervention to Improve Cognitive Function

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Health education; Behavioral: Structured physical activity

• Registration Number: NCT02248649
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Study Start: 2014-12-01
• Primary Completion: 2018-05-15
• Study Completion: 2018-09-30
• Status Verified: 2019-05
• Results First Submitted: 2019-05-20
• Results First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Results First Posted: 2019-07-24
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

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Exclusion Criteria

• Angina pectoris
• History of myocardial infarction within 6 months
• History of ventricular dysrhythmia requiring current therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Health education	Health education attention control
Physical Activity	Structured physical activity	Structured walking program

Primary Outcome Measures

Name	Time	Method
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6	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 Outcome Measures

Name	Time	Method
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12	Baseline and 12 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 12-month - Score at Baseline.
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18	Baseline and 18 month	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 12-month - Score at Baseline.

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States