Parkinson's Disease Clinical Trial
Official title:
Exercise, Physical Function, and Parkinson's Disease
This study is designed to compare three different exercise approaches to learn which program is best for people with early and mid-stage Parkinson's disease. Results from this study will help determine if participants can maintain the benefits from exercise and will help determine which program people with Parkinson's disease are more likely to continue using.
This is an intervention study that will determine whether an exercise program targeting
spinal extremity range of motion for individuals with Parkinson's Disease, is superior to
general conditioning and to 'usual care'. This study builds on previous findings of
Schenkman and colleagues including the following: loss of spinal and extremity range of
motion occur as sequelae to PD; these losses contribute significantly to early impairments
of balance; and both spinal range of motion and balance of people with economy of movement
is impaired in people who have PD. Specifically, we will examine whether the intervention,
targeting range of motion and balance, also improves economy of movement.
Untreated impairments of range of motion, balance, and economy of movement may become highly
disabling. Short term improvements of range of motion and balance occur with exercise. If
the patient can sustain such improvements after a supervised exercise program is completed,
these functionally limiting impairments may be delayed. Additionally, if exercises for
spinal range of motion are coupled with functional retraining, the patient should improve in
overall physical functional ability. Therefore, this study will establish the overall impact
of a targeted exercise program for people with PD in terms of balance, economy of movement,
and overall functional ability.
The study is a randomized clinical trial, with three treatment arms and four repeated
measures: before treatment, after treatment, and follow-up after 10 months and again after
16 months. This study compares usual care based on the National Parkinson's Foundation,
aerobic training, and targeted flexibility and functional training. The primary outcomes are
measures of overall functional ability, balance and economy of movement. Secondary outcomes
include measures of disease state, spinal range of motion, aerobic capacity, and quality of
life.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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