Exercise for People With Parkinson's Disease

Study Overview
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Brief Summary
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This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.

Detailed Description
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This randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid-stages of Parkinson's disease. Two different approaches to exercise are compared to standard of care. The two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. The standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. Functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. This study is the first long term exercise study for people with Parkinson's disease PD of which we are aware and is the most comprehensive examination of exercise for people with PD to date. Results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of PD, both in terms of immediate 4 month and long term 16 month effects.

Official Title
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Exercise, Physical Function, and Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Aerobic Exercise
* Behavioral: Flexibility and Function exercise program
* Behavioral: Home exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Parkinson's Disease Hoehn & Yahr stages 1-3.5 Exclusion Criteria: Cardiovascular contraindications to aerobic exercise Reliance on walker or wheelchair Psychiatric conditions DBS or other surgeries Any other conditions that would interfere with exercise

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexibility & Function<br>Subjects take part in an exercise program based on flexibility and function. | Behavioral: Flexibility and Function exercise program<br> <br> |
| Experimental: Aerobic Exercise<br>Subjects will take part in an aerobic exercise program | Behavioral: Aerobic Exercise<br> <br> |
| Other: Home exercise<br>Standard of care home exercise program | Behavioral: Home exercise program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Reach | Measure of balance | baseline, 4, 10, 16 months |