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临床试验/NCT03337464
NCT03337464已完成不适用

The Effects of a Single Bout of Exercise in Parkinson's Disease.

Pacific Parkinson's Research Centre1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
EEG-EMG coherence

研究概览

简要总结

To assess 30 active people (15 with PD, 15 without) before and after 30 minutes of pedaling exercise using EEG-EMG, cognitive, mood and motor assessments.

详细描述

Purpose: To assess 15 subjects with PD and 15 healthy controls, who exercise on a regular basis, before, during and after 30 minutes of pedaling exercise intervention. The investigators will assess subjects for alterations in motor cortex assessment, cognition and mood as measured by EMG/EEG, motor assessment and several batteries of questionnaires. Findings from this study will lay the foundation for long-term studies.

Hypotheses: The investigators anticipate to observe an altered involvement of motor cortex during steady pedaling in individuals suffering from PD. In healthy control subjects it is anticipated that changes in cognition will be observable.

Justification: Hindered movement initiation and continuing locomotion is a common syndrome in PD with profound impact on the patient's mobility and quality of life. So far, the underlying pathophysiology is not completely understood. Since the observation that cortical activity contributes to the muscle activity during locomotion-like tasks underpins the importance of corticospinal function in humans, it is of importance to examine whether this cortical involvement is altered and displays abnormalities in patients with PD. Thus, the approach of corticomuscular coupling during a locomotion-like task would allow for better understanding of the pathophysiology of PD, a prerequisite to develop therapies. Findings of this study will lay the foundation for future long-term studies.

Additionally, by examining the oscillatory EEG patterns during the exercise intervention, the investigator will be able to read out the dose response curve in real time, which will provide information on the optimum intensity and duration of exercise. Findings will help to design future studies and to develop efficient exercise therapy interventions for people with PD.

People living with PD often suffer from cognitive decline, depression, and fatigue. By assessing cognitive function before and after the exercise intervention, there will be laid a foundation for future studies investigating the effect of exercise on cognition. The collected pilot data will be relevant to learn more about the effects of exercise on mood and fatigue as well as concomitant obstacles and facilitators during exercise interventions in patients with PD.

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
Single (Outcomes Assessor)

盲法说明

The assessor will be blinded to subject group and intervention.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult between 40-80 years
  • •Hoehn and Yahr stage I-III
  • •Exercise on a regular basis (at least 100 minutes of aerobic exercise per week)
  • •Montreal Cognitive Assessment score >/= 24
  • •Able to communicate with study personnel
  • •Able to be informed of the nature of the study and willing to give written consent form

排除标准

  • •Hoehn and Yahr stages IV-V
  • •Significant cardiovascular disease
  • •Previous stroke
  • •Not exercising on a regular basis
  • •Functional disabling dyskinesia
  • •Functional disabling dystonia
  • •Significant neurological or psychiatric illness other than PD
  • •Severe depression
  • •Significant musculoskeletal disorder (e.g. arthritis)
  • •Significant metabolic disorder (e.g. diabetes)
  • •Brain surgery in the past
  • •Currently taking beta blocker medication

研究组 & 干预措施

Parkinson's disease

Experimental

Subjects with Parkinson's disease

干预措施: cycling exercise (Other)

Control

Active Comparator

Subjects without Parkinson's disease

干预措施: cycling exercise (Other)

结局指标

主要结局

EEG-EMG coherence

时间窗: The change from immediately before, during, and immediatly after the single bout of exercise.

Coherence of the coupling between EEG and EMG from active leg muscles during cycling on a stationary bicycle both in subjects with PD and age and gender matched healthy controls.

次要结局

  • Motor function(Immediately before and after the single bout of exercise.)
  • Cognitive function(Immediately before, after and at 3 hours following the single bout of exercise.)
  • Mood function(Immediately before, after and at 3 hours following the single bout of exercise.)

研究者

发起方
Pacific Parkinson's Research Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Jon Stoessl

Clinical Director of PET

Pacific Parkinson's Research Centre

研究点 (1)

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