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

This study has been completed.
Sponsor:
Collaborator:
Kinetics Foundation
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00982709
First received: September 22, 2009
Last updated: June 24, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention
Exercise
Parkinson's Disease
Behavioral: Aerobic vs. Agility Training

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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Dynamic Posturography [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UPDRS [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Types
comparing two different exercise programs for PD
Behavioral: Aerobic vs. Agility Training
High Intensity 4x's per week for 4 weeks with a physical therapist.
Other Name: agility, treadmill

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Idiopathic PD

Exclusion Criteria:

  • Other neurological conditions, artificial joints
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00982709

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Kinetics Foundation
  More Information

No publications provided

Responsible Party: Fay Horak, OHSU
ClinicalTrials.gov Identifier: NCT00982709     History of Changes
Other Study ID Numbers: 4402
Study First Received: September 22, 2009
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 24, 2014