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临床试验/NCT01768832
NCT01768832已完成不适用

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

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
2
主要终点
Walking Velocity at Baseline and 3 Months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Treadmill

Experimental

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

干预措施: Treadmill (Behavioral)

Tango

Experimental

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

干预措施: Tango (Behavioral)

Stretching

Active Comparator

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

干预措施: Stretching (Behavioral)

结局指标

主要结局

Walking Velocity at Baseline and 3 Months

时间窗: 0 and 3 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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