Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatments structured exercise, lifestyle exercise
Phase phase 3
Sponsor VA Office of Research and Development
Start date January 2013
End date March 2016
Trial size 158 participants
Trial identifier NCT01639469, IIR 11-342

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
Structured exercise instruction by smartphone
structured exercise
Structured exercise includes stretching, strengthening, and balance exercises.
(Active Comparator)
Lifestyle exercise program taught via smartphone
lifestyle exercise
Subjects will be taught lifestyle exercises and advised about mobility strategies

Primary Outcomes

Measure
Fall rate
time frame: 1 year

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title A Telemedicine Intervention to Improve Physical Function in Patients With PD
Principal investigator David William Sparrow, DSc
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: We 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.