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Completed

NCT Number: NCT01768832

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill

Behavioral

Tango

Behavioral

Stretching

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2013
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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