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临床试验/NCT01701128
NCT01701128终止不适用

The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease

Laval University4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
35
试验地点
4
主要终点
Change in Gait speed

研究概览

简要总结

The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and without a strengthening component, on functional mobility, gait and quality of life in patients with Parkinson's disease (PD). The rationale for a study of this type stems from the hypothesis that treadmill training may act as an external "pacemaker" and enhance some properties of gait. There is a need for larger scale randomized controlled trials comparing the effects of treadmill training to control groups that receive similar amounts of attention. To date, no study has combined TT and muscle strengthening, likely the optimal form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72 one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill training will considerably improve walking parameters and the well being of people with PD.

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • Diagnosis of idiopathic Parkinson's disease
  • Stage of II or less on Hoehn and Yahr scale

排除标准

  • Having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program
  • Dementia (MMSE<24)
  • Having balance problems
  • Live beyond 45 minutes from Laval University

结局指标

主要结局

Change in Gait speed

时间窗: Baseline, 3 and 6 months

This measure was recorded using the GAITrite system

Change in Endurance walking

时间窗: Baseline, 3 and 6 months

This measure was recorded using the 6-minutes walk test

Change in Quality of life

时间窗: Baseline, 3 and 6 months

This measure was recorded using PDQ-39

次要结局

  • Change in Postural Balance(Baseline, 3 and 6 months)
  • Change in Spatiotemporal parameters of walking(Baseline, 3 and 6 months)
  • Change in Cognitive impairment(Baseline, 3 and 6 months)
  • Change in Fear of falling(Baseline, 3 and 6 months)
  • Change in Depression and anxiety level(Baseline, 3 and 6 months)
  • Change in Effects of symptoms and motor impairment(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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