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

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ClinicalTrials.gov Identifier: NCT01768832
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Treadmill Behavioral: Tango Behavioral: Stretching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Study Start Date : February 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treadmill
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Behavioral: Treadmill
Experimental: Tango
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Behavioral: Tango
Active Comparator: Stretching
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Behavioral: Stretching



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Blood Oxygen Level Dependent Signal at Baseline to 3 Months [ Time Frame: 0 and 3 months ]
    Measure of the ratio of oxygenated to deoxygenated blood in areas of the brain at a specific time. Used as an indirect assessment of brain activity and connections. Higher values indicate more brain activity in the brain areas of interest.

  2. Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months [ Time Frame: 0 and 3 months ]
    The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.

  3. PDQ-39 Scores at Baseline and 3 Months [ Time Frame: 0 and 3 months ]
    The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.

  4. Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months [ Time Frame: 0 and 3 months ]
    The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.

  5. Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months [ Time Frame: 3 and 6 months ]
    The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.

  6. Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months [ Time Frame: 3 and 6 months ]
    The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.

  7. PDQ-39 Scores at 3 Months and 6 Months [ Time Frame: 3 and 6 months ]
    The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.

  8. Walking Velocity at 3 Months and 6 Months [ Time Frame: 3 and 6 months ]
    Walking velocity during forward and backward walking as determined by a computerized mat.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of Parkinson disease
  2. at least grade 3/5 strength and normal joint ranges of motion in both legs,
  3. vision corrected to 20/40 or better,
  4. 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),

6) no history of vestibular disease, 7) no evidence of dementia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768832


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Gammon M Earhart, PhD, PT Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01768832    
Other Study ID Numbers: 1R01NS077959-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2013    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: November 2018
Keywords provided by Washington University School of Medicine:
Parkinson disease
walking
fMRI
exercise
dance
treadmill
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases