The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Primary Purpose
Exercise, Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic vs. Agility Training
Sponsored by
About this trial
This is an interventional treatment trial for Exercise
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Idiopathic PD
Exclusion Criteria:
- Other neurological conditions, artificial joints
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Exercise Types
Arm Description
comparing two different exercise programs for PD
Outcomes
Primary Outcome Measures
Dynamic Posturography
Secondary Outcome Measures
UPDRS
Full Information
NCT ID
NCT00982709
First Posted
September 22, 2009
Last Updated
October 31, 2014
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00982709
Brief Title
The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Official Title
The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim:
To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used to quantify balance and gait performance before and after two PT-supervised, intensive, exercise programs, expected to improve balance and gait. The first program is a published Treadmill training program and the second is the investigators new Agility training program with sensorimotor progressions, targeted at specific impairments that underlie the abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in preparation for a larger clinical trial to determine the most effective exercise for mobility disability in PD. The effects of exercise will be compared with no treatment during a 5-week delay prior to start of exercise.
This trial will also determine the relative responsiveness (compared to traditional clinical scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to show there is a difference between the exercise groups. Superior responsiveness of the iMOBILITY system will be determined by larger differences with exercise intervention with the iMOBILITY system than with traditional clinical measures of mobility in PD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Types
Arm Type
Active Comparator
Arm Description
comparing two different exercise programs for PD
Intervention Type
Behavioral
Intervention Name(s)
Aerobic vs. Agility Training
Other Intervention Name(s)
agility, treadmill
Intervention Description
High Intensity 4x's per week for 4 weeks with a physical therapist.
Primary Outcome Measure Information:
Title
Dynamic Posturography
Time Frame
pre and post intervention
Secondary Outcome Measure Information:
Title
UPDRS
Time Frame
pre and post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Idiopathic PD
Exclusion Criteria:
Other neurological conditions, artificial joints
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
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The Effects of Treadmill Versus Agility Training in Parkinson's Disease
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