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Telemedicine Intervention to Improve Physical Function

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VA Office of Research and Development

Status

Completed

Conditions

Parkinson's Disease

Treatments

Behavioral: Structured exercise
Behavioral: Lifestyle exercise

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01639469
IIR 11-342

Details and patient eligibility

About

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.

Full 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.

Enrollment

169 patients

Sex

All

Ages

40+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

169 participants in 2 patient groups

Structured exercise
Experimental group
Description:
Structured exercise instruction by smartphone
Treatment:
Behavioral: Structured exercise
lifestyle exercise
Active Comparator group
Description:
Lifestyle exercise program taught via smartphone
Treatment:
Behavioral: Lifestyle exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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