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Completed

NCT Number: NCT01639469

Telemedicine Intervention to Improve Physical Function

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured exercise

Behavioral

Structured exercise includes stretching, strengthening, and balance exercises.

Lifestyle exercise

Behavioral

Subjects will be taught lifestyle exercises and advised about mobility strategies

Primary outcomes

  1. Total Falls During the 1-year Follow-up

    Time frame: up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

A Telemedicine Intervention to Improve Physical Function in Patients With PD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2012
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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