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| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | May 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004760 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Axial Mobility Exercises in Parkinson Disease | ||||
| Official Title ICMJE | |||||
| Brief Summary | OBJECTIVES: I. Compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with Parkinson disease. |
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| Detailed Description | PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility Exercise Program participate 3 times a week for 10 weeks. The program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks. Patients assigned to the control group receive standard care (no exercise). |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training | ||||
| Condition ICMJE | Parkinson Disease | ||||
| Intervention ICMJE | Behavioral: Exercise | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | December 1997 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Stage 2 or 3 Parkinson disease (Hoehn/Yahr scale) Able to ambulate independently Able to function independently in home Moderate rigidity No moderate or severe tremor --Prior/Concurrent Therapy-- Concurrent stable pharmacologic regimen required --Patient Characteristics-- Cardiovascular: No unstable angina Other: No psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of Duke University |
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| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004760 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/11694, DUMC-722955R2 | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | April 1998 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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