Telemedicine Intervention to Improve Cognitive Function
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured physical activity
Health education
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, Exercise therapy, Mild cognitive impairment
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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical Activity
Control
Arm Description
Structured walking program
Health education attention control
Outcomes
Primary Outcome Measures
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
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
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12
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
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.
Full Information
NCT ID
NCT02248649
First Posted
September 22, 2014
Last Updated
May 20, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02248649
Brief Title
Telemedicine Intervention to Improve Cognitive Function
Official Title
A Telemedicine Intervention to Improve Cognitive Function in Patients With PD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Exercise therapy, Mild cognitive impairment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
Structured walking program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Health education attention control
Intervention Type
Behavioral
Intervention Name(s)
Structured physical activity
Intervention Description
Walking instruction and encouragement
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Provision of general information about a variety of health topics
Primary Outcome Measure Information:
Title
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12
Description
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.
Time Frame
Baseline and 12 months
Title
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18
Description
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.
Time Frame
Baseline and 18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine Intervention to Improve Cognitive Function
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