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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Stretching; Behavioral: Treadmill; Behavioral: Tango

• Registration Number: NCT01768832
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Study Start: 2013-02
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2018-08-17
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Results First Posted: 2018-11-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stretching	Stretching	Individuals assigned to Stretching will complete two one hour stretching classes per week for 12 weeks.
Treadmill	Treadmill	Individuals assigned to the Treadmill group will complete two one hour treadmill training sessions per week for 12 weeks.
Tango	Tango	Individuals assigned to the Tango group will complete two one hour dance classes twice per week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Walking Velocity at Baseline and 3 Months	0 and 3 months	Walking velocity during forward and backward walking as determined by a computerized mat.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States