Telemedicine Intervention to Improve Physical Function

Parkinson's Disease Clinical Trial

Official title:

A Telemedicine Intervention to Improve Physical Function in Patients With PD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639469
• Other study ID #: IIR 11-342
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: June 22, 2017
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Structured exercise
Structured exercise includes stretching, strengthening, and balance exercises.
• Lifestyle exercise
Subjects will be taught lifestyle exercises and advised about mobility strategies

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 year