Telemedicine Intervention to Improve Cognitive Function

NCT ID: NCT02248649

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2018-09-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Physical Activity

Structured walking program

Group Type: EXPERIMENTAL

Structured physical activity

Intervention Type: BEHAVIORAL

Walking instruction and encouragement

Control

Health education attention control

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: BEHAVIORAL

Provision of general information about a variety of health topics

Interventions

Structured physical activity

Walking instruction and encouragement

Intervention Type: BEHAVIORAL

Health education

Provision of general information about a variety of health topics

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W Sparrow, DSc

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

N1696-I

Identifier Type: -

Identifier Source: org_study_id