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Telemedicine Intervention to Improve Physical Function

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured exercise
Lifestyle exercise
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson Disease, Quality of Life, Exercise Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Structured exercise

lifestyle exercise

Arm Description

Structured exercise instruction by smartphone

Lifestyle exercise program taught via smartphone

Outcomes

Primary Outcome Measures

Total Falls During the 1-year Follow-up
Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2012
Last Updated
June 22, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01639469
Brief Title
Telemedicine Intervention to Improve Physical Function
Official Title
A Telemedicine Intervention to Improve Physical Function in Patients With PD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life in patients with Parkinson's disease.
Detailed Description
Background/Rationale: Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD are motoric, which limit functional mobility leading to difficulty working, caring for family members, managing a household, and overall decreased independence and quality of life (QOL). A wealth of growing data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established. Objective: The investigators hypothesize that a one-year in-home exercise program, centered around remote, real-time instruction and supervision, will reduce the rate of falls and improve strength and QOL in patients with PD. Methods: The proposed study is a randomized controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. Community-dwelling people with PD will be randomized either to a group who receives structured and remote exercise instruction and supervision in real-time or a group who is taught a lifestyle exercise program. 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, and response to dopaminergic medication. The interventions will last one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson Disease, Quality of Life, Exercise Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured exercise
Arm Type
Experimental
Arm Description
Structured exercise instruction by smartphone
Arm Title
lifestyle exercise
Arm Type
Active Comparator
Arm Description
Lifestyle exercise program taught via smartphone
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise
Intervention Description
Structured exercise includes stretching, strengthening, and balance exercises.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle exercise
Intervention Description
Subjects will be taught lifestyle exercises and advised about mobility strategies
Primary Outcome Measure Information:
Title
Total Falls During the 1-year Follow-up
Description
Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.
Time Frame
up to 1 year

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 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

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Telemedicine Intervention to Improve Physical Function

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