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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill
Tango
Stretching
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, walking, fMRI, exercise, dance, treadmill

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treadmill

Tango

Stretching

Arm Description

Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.

Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.

Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.

Outcomes

Primary Outcome Measures

Walking Velocity at Baseline and 3 Months
Walking velocity during forward and backward walking as determined by a computerized mat.

Secondary Outcome Measures

Blood Oxygen Level Dependent Signal at Baseline to 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.
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline 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.
PDQ-39 Scores at Baseline 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.
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 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.
Mini Balance Evaluation Systems Test (Mini-BESTest) at 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.
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months 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.
PDQ-39 Scores at 3 Months 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.
Walking Velocity at 3 Months and 6 Months
Walking velocity during forward and backward walking as determined by a computerized mat.

Full Information

First Posted
January 8, 2013
Last Updated
November 14, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01768832
Brief Title
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Official Title
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, walking, fMRI, exercise, dance, treadmill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill
Arm Type
Experimental
Arm Description
Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Arm Title
Tango
Arm Type
Experimental
Arm Description
Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.
Arm Title
Stretching
Arm Type
Active Comparator
Arm Description
Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill
Intervention Type
Behavioral
Intervention Name(s)
Tango
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Primary Outcome Measure Information:
Title
Walking Velocity at Baseline and 3 Months
Description
Walking velocity during forward and backward walking as determined by a computerized mat.
Time Frame
0 and 3 months
Secondary Outcome Measure Information:
Title
Blood Oxygen Level Dependent Signal at Baseline to 3 Months
Description
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.
Time Frame
0 and 3 months
Title
Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months
Description
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.
Time Frame
0 and 3 months
Title
PDQ-39 Scores at Baseline and 3 Months
Description
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.
Time Frame
0 and 3 months
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months
Description
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.
Time Frame
0 and 3 months
Title
Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months
Description
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.
Time Frame
3 and 6 months
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months
Description
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.
Time Frame
3 and 6 months
Title
PDQ-39 Scores at 3 Months and 6 Months
Description
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.
Time Frame
3 and 6 months
Title
Walking Velocity at 3 Months and 6 Months
Description
Walking velocity during forward and backward walking as determined by a computerized mat.
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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), 6) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gammon M Earhart, PhD, PT
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30531383
Citation
Rawson KS, McNeely ME, Duncan RP, Pickett KA, Perlmutter JS, Earhart GM. Exercise and Parkinson Disease: Comparing Tango, Treadmill, and Stretching. J Neurol Phys Ther. 2019 Jan;43(1):26-32. doi: 10.1097/NPT.0000000000000245.
Results Reference
derived
PubMed Identifier
25652002
Citation
Earhart GM, Duncan RP, Huang JL, Perlmutter JS, Pickett KA. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial. BMC Neurol. 2015 Feb 5;15:9. doi: 10.1186/s12883-015-0261-0.
Results Reference
derived

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

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