The Effects of Treadmill Versus Agility Training in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

The Effects of Treadmill Versus Agility Training in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982709
• Other study ID #: 4402
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: October 31, 2014
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: October 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Idiopathic PD

Exclusion Criteria:

• Other neurological conditions, artificial joints

Study Design

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

Related Conditions & MeSH terms

• Exercise
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Aerobic vs. Agility Training
High Intensity 4x's per week for 4 weeks with a physical therapist.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Posturography		pre and post intervention	No
Secondary	UPDRS		pre and post intervention	No