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Clinical Trials/NCT01257945
NCT01257945
Completed
Phase 2

Exercise, Physical Function, and Parkinson's Disease

University of Colorado, Denver1 site in 1 country163 target enrollmentApril 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Colorado, Denver
Enrollment
163
Locations
1
Primary Endpoint
Functional Reach
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
July 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional Reach

Time Frame: baseline, 4, 10, 16 months

Measure of balance

Study Sites (1)

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