Exercise for People With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Exercise, Physical Function, and Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257945
• Other study ID #: 02-0750
• Secondary ID: R01HD043770
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2010
• Last updated: October 1, 2012
• Start date: April 2003
• Est. completion date: July 2010

Study information

• Verified date: October 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Aerobic Exercise

• Flexibility and Function exercise program

• Home exercise program

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Christiansen CL, Schenkman ML, McFann K, Wolfe P, Kohrt WM. Walking economy in people with Parkinson's disease. Mov Disord. 2009 Jul 30;24(10):1481-7. doi: 10.1002/mds.22621. — View Citation

Schenkman M, Hall D, Kumar R, Kohrt WM. Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Phys Ther. 2008 Jan;88(1):63-76. Epub 2007 Oct 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Reach	Measure of balance	baseline, 4, 10, 16 months	No