Exercise for People With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Flexibility and Function exercise program
Home exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Flexibility & Function
Aerobic Exercise
Home exercise
Arm Description
Subjects take part in an exercise program based on flexibility and function.
Subjects will take part in an aerobic exercise program
Standard of care home exercise program
Outcomes
Primary Outcome Measures
Functional Reach
Measure of balance
Secondary Outcome Measures
Full Information
NCT ID
NCT01257945
First Posted
December 7, 2010
Last Updated
October 1, 2012
Sponsor
University of Colorado, Denver
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01257945
Brief Title
Exercise for People With Parkinson's Disease
Official Title
Exercise, Physical Function, and Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexibility & Function
Arm Type
Experimental
Arm Description
Subjects take part in an exercise program based on flexibility and function.
Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Subjects will take part in an aerobic exercise program
Arm Title
Home exercise
Arm Type
Other
Arm Description
Standard of care home exercise program
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Type
Behavioral
Intervention Name(s)
Flexibility and Function exercise program
Intervention Type
Behavioral
Intervention Name(s)
Home exercise program
Primary Outcome Measure Information:
Title
Functional Reach
Description
Measure of balance
Time Frame
baseline, 4, 10, 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Schenkman
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19441128
Citation
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.
Results Reference
background
PubMed Identifier
17940108
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. doi: 10.2522/ptj.20060351. Epub 2007 Oct 16.
Results Reference
result
PubMed Identifier
22822237
Citation
Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012 Nov;92(11):1395-410. doi: 10.2522/ptj.20110472. Epub 2012 Jul 19.
Results Reference
derived
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Exercise for People With Parkinson's Disease
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