Exercise for People With Parkinson's Disease

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Flexibility and Function exercise program; Behavioral: Home exercise program; Behavioral: Aerobic Exercise

• Registration Number: NCT01257945
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• Clinical diagnosis of Parkinson's Disease
• Hoehn & Yahr stages 1-3.5

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexibility & Function	Flexibility and Function exercise program	Subjects take part in an exercise program based on flexibility and function.
Home exercise	Home exercise program	Standard of care home exercise program
Aerobic Exercise	Aerobic Exercise	Subjects will take part in an aerobic exercise program

Primary Outcome Measures

Name	Time	Method
Functional Reach	baseline, 4, 10, 16 months	Measure of balance

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States