Status:
UNKNOWN
Exercise Study For People With Parkinson's Disease
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
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 determin...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
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Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00387218
Start Date
December 1 2002
End Date
April 1 2009
Last Update
May 23 2008
Active Locations (4)
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1
Waldron's Peak Physical Therapy
Boulder, Colorado, United States, 80303
2
Penrose Hospital
Colorado Springs, Colorado, United States, 80933
3
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262
4
Carmody Recreation Center
Lakewood, Colorado, United States, 80227