Exercise Study For People With Parkinson's Disease

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.

Inclusion Criteria: Community dwelling, independently ambulatory adults with mild to
moderate PD (Stages 2, 2.5, and 3 on the modified Hoehn and Yahr scale) will be included.
For inclusion, study subjects must have a diagnosis of PD made by their attending
neurologist using criteria from the UK Brain Bank (e.g., at least two of the cardinal
signs of PD [i.e., bradykinesia, resting tremor, rigidity, postural instability]); without
PD medication other known or suspected causes of parkinsonism. They must be on a stable
regimen for at least one month prior to enrollment, and must be receiving optimal
medication management in the judgment of the examining neurologist.

Exclusion Criteria: Participants will be excluded if: on-state freezing; hospitalized
within the previous three months, a score on the Folstein Mini-Mental Status Exam of less
than 25 (indicating significant dementia); non-drug induced psychosis, or drug induced
hallucinations, off periods of >25% time (UPDRS part IV)[3] or sub-optimal therapy of
Parkinson's disease motor or non-motor symptoms; a second neurological disorder (e.g.
stroke) with resulting motor involvement, or poorly controlled or unstable cardiovascular
disease that precludes participation in the exercise program. In addition, participants
will be excluded if they are participating in another trial except for those
investigations that meet the following criteria: 1) PD Trial that is not related to the
symptoms of PD (e.g., genetics of PD); 2) stable dose of an investigational medication
given to treat motor symptoms of Parkinson's disease on an open-label basis or 3) in a
trial that is not expected to affect PD or movement (e.g., hypertension, diabetes). They
will be excluded if they cannot speak English and do not have adequate interpretation to
participate in all aspects of the study.

Other exclusion criteria include presence of atypical parkinsonism syndromes due to drugs
(e.g., metoclopramide, flunarizine), metabolic neurogenetic disorders (e.g., Wilson's
disease), encephalitis, cerebrovascular, or degenerative disease (e.g. progressive
supranuclear palsy, multiple system atrophy, vascular parkinsonism), history of
pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant. Finally,
participants will be excluded if they have any other clinically significant medical
condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality which
would, in the judgement of the investigator, interfere with the subject's ability to
participate in the study.

Additional exclusions are: 1) exercise limiting neuromuscular, joint/bone, cardiovascular,
peripheral vascular, cerebrovascular or pulmonary disease; 2) abnormal treadmill stress
test or contraindication to testing (recent MI, CHF, pulmonary embolus, significant aortic
stenosis); 3) uncontrolled hypertension; 4) unstable diabetes or other endocrinopathy; 5)
active liver disease (>3X normal LFTs); 6) major psychiatric illness that would affect the
ability to understand and cooperate fully with the study protocol; 7) massive obesity
(BMI>40); anemia; 8) consistent use of alcohol (>2 drinks/d); 9) involvement in an ongoing
exercise program (>2Xwk for 20 min at an intensity that could produce sweating) in the
last 6 months.