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临床试验/NCT01639469
NCT01639469已完成不适用

A Telemedicine Intervention to Improve Physical Function in Patients With PD

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
2
主要终点
Total Falls During the 1-year Follow-up

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
  • At least 2 of 3 cardinal signs of PD
  • Response to dopaminergic medication

排除标准

  • Angina pectoris
  • History of myocardial infarction within 6 months
  • History of ventricular dysrhythmia requiring current therapy

结局指标

主要结局

Total Falls During the 1-year Follow-up

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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