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Clinical Trials/NCT01768832
NCT01768832
Completed
Not Applicable

Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms

Washington University School of Medicine1 site in 1 country119 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Washington University School of Medicine
Enrollment
119
Locations
1
Primary Endpoint
Walking Velocity at Baseline and 3 Months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. In particular, dance and treadmill training have been individually shown to improve walking performance and quality of life. At present it is not clear whether dance or treadmill training have similar effects or if one is superior to the other. Furthermore, our understanding of the means by which these exercise interventions convey benefits is extremely limited. This study aims to address these knowledge gaps by directly comparing dance, treadmill training and stretching (control group). The primary area of interest is the effects on gait, with secondary measures of disease severity, balance, and quality of life. The investigators will determine not only the effects of the interventions on walking performance, but will also investigate the effects of the interventions on connections between different parts of the brain and on brain function during imagined walking tasks using functional magnetic resonance imaging (fMRI). Participants will be randomly assigned to dance, treadmill training, or a stretching/flexibility control group. Participants will be assessed over a period of 6 months at 3 different time points. The investigators hypothesize that both dance and treadmill training will lead to improvements in forward walking, but that dance will result in greater improvements in backward walking compared to treadmill training. Furthermore, the investigators hypothesize that the tango and treadmill interventions will have different effects of brain function and brain connections. The investigators expect dance to enhance the activity and connections of particular brain regions and treadmill training to enhance activity and connections of different brain regions. The investigators do not expect changes in brain activity or connections in the control group.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of Parkinson disease
  • at least grade 3/5 strength and normal joint ranges of motion in both legs,
  • vision corrected to 20/40 or better,
  • able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),
  • no history of vestibular disease, 7) no evidence of dementia

Exclusion Criteria

  • medical condition for which exercise is contraindicated,
  • evidence of abnormality other than PD-related changes on brain imaging,
  • history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,
  • history or evidence of orthopedic or muscular problem,
  • failed to pass magnetic resonance imaging screening procedure

Outcomes

Primary Outcomes

Walking Velocity at Baseline and 3 Months

Time Frame: 0 and 3 months

Walking velocity during forward and backward walking as determined by a computerized mat.

Secondary Outcomes

  • PDQ-39 Scores at Baseline and 3 Months(0 and 3 months)
  • Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months(3 and 6 months)
  • PDQ-39 Scores at 3 Months and 6 Months(3 and 6 months)
  • Blood Oxygen Level Dependent Signal at Baseline to 3 Months(0 and 3 months)
  • Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months(0 and 3 months)
  • Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months(0 and 3 months)
  • Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months(3 and 6 months)
  • Walking Velocity at 3 Months and 6 Months(3 and 6 months)

Study Sites (1)

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