Status:
COMPLETED
Study in Parkinson's Disease of Exercise
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of Illinois at Chicago
University of Pittsburgh
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of e...
Detailed Description
The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The...
Eligibility Criteria
Inclusion
- Clinical diagnosis of primary Parkinson's disease
- In a Hoehn and Yahr stage less than stage III
- Disease duration is less than 5 years
- Not likely to require dopaminergic therapy within 6 months
Exclusion
- Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
- Duration of previous use of medications for PD that exceeds 90 days
- Expected to require dopaminergic therapy in the next 6 months
- Poorly controlled or unstable cardiovascular disease
- Uncontrolled hypertension
- Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
- Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
- Depression that precludes ability to exercise (Beck depression score\>13)
- Disorders that interfere with ability to perform endurance exercises
- Regular participation in vigorous endurance exercise
- Evidence of serious arrhythmias or ischemic heart disease
- Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01506479
Start Date
May 1 2012
End Date
November 1 2016
Last Update
October 13 2017
Active Locations (3)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
University of Illinois, Chicago
Chicago, Illinois, United States, 60612
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213