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临床试验/NCT03701776
NCT03701776已完成不适用

Effects of Aerobic Exercise Verse Balance Training on Degenerative Cerebellar Disease

Columbia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Change in SARA scores

研究概览

简要总结

The first aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression.

The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

详细描述

Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

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)

盲法说明

The outcome assessor will know that the participant has received balance or aerobic training, but will not be aware of which group the participant belonged.

入排标准

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

入选标准

  • Diagnosed with spinocerebellar ataxia
  • Cerebellar atrophy on MRI
  • Prevalence of ataxia on clinical exam
  • Ability to safely ride a stationary exercise bike

排除标准

  • Other neurologic conditions
  • Heart disease
  • Cognitive impairment
  • Medical instability

结局指标

主要结局

Change in SARA scores

时间窗: 6 months

Ataxia severity will be measured using the Scale for the Assessment and Rating of Ataxia (SARA).17 SARA evaluates the degree of ataxia by measuring gait, stance, sitting balance, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test.

次要结局

  • Change in gait parameters(6 months)
  • Change in cerebellar volume(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Barbuto

Assistant Professor of Physical Medicine and Rehabilitation

Columbia University

研究点 (1)

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