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临床试验/NCT04114318
NCT04114318已完成不适用

The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease

Chang Gung Memorial Hospital0 个研究点目标入组 26 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
主要终点
Double limb support time in second

研究概览

简要总结

The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.

详细描述

Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.

Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.

Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.

Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with Idiopathic Parkinson's disease (IPD)
  • an age between 45 to 70 years
  • asymmetrical onset of at least 2 of 3 cardinal sign
  • Modified Hoehn and Yahr staging from 1 to 2.5 during off state
  • Montreal cognitive assessment score of 26 or greater

排除标准

  • The patients were ineligible if they had
  • a neurological history other than Parkinson's disease
  • ever undergone neurosurgery for Parkinson's disease
  • had moderate to severe dyskinesia
  • been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise
  • done more than 20 min of aerobic exercise over 3 sessions per week on their own

结局指标

主要结局

Double limb support time in second

时间窗: 5 minutes

using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

Step length in cm

时间窗: 5 minutes

using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

Modified Hoehn and Yahr staging

时间窗: 5 minutes

scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease.

Gait speed in cm/second

时间窗: 5 minutes

using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

Step time in second

时间窗: 5 minutes

using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

Time up and go test in second

时间窗: 2 minutes

The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility

Unified Parkinson's disease rating scale

时间窗: 30 minutes

There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome.

Step width in cm

时间窗: 5 minutes

using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway

次要结局

  • Cognitive performance(10 minutes)
  • Dual-task interference(10 minutes)
  • Adverse event(5 minutes)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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