Telemedicine Intervention to Improve Physical Function
|ClinicalTrials.gov Identifier: NCT01639469|
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: Structured exercise Behavioral: Lifestyle exercise||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Telemedicine Intervention to Improve Physical Function in Patients With PD|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Structured exercise
Structured exercise instruction by smartphone
Behavioral: Structured exercise
Structured exercise includes stretching, strengthening, and balance exercises.
Active Comparator: lifestyle exercise
Lifestyle exercise program taught via smartphone
Behavioral: Lifestyle exercise
Subjects will be taught lifestyle exercises and advised about mobility strategies
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639469
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||David W Sparrow, DSc||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|