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临床试验/NCT04340492
NCT04340492已完成不适用

Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年3月15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
89
试验地点
2
主要终点
Change in time spent in moderate to vigorous physical activity during one week

研究概览

简要总结

Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset.

Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors.

The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.

研究设计

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

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suffering from Parkinson's disease according to Movement Disorders Society criteria,
  • with a diagnosis of Parkinson for 3 years or less,
  • with a stable treatment for Parkinson's disease for 3 months or more,
  • having signed the consent form

排除标准

  • Woman child-bearing or breath-feeding
  • Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy…)
  • Major depressive disorder according to DSM-V
  • Significant cognitive trouble (MOCA<23)
  • Atypical parkinson's

研究组 & 干预措施

Adapted Physical Activity group

Experimental

干预措施: Education to Adapted Physical Activity (Other)

control group

Sham Comparator

干预措施: Standard care (Other)

结局指标

主要结局

Change in time spent in moderate to vigorous physical activity during one week

时间窗: between baseline and 6 months after baseline

Daily physical activity is assessed with an actimeter (Actigraph GT9X).

次要结局

  • Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)(between baseline and 6 months after baseline)
  • Percentage of patients that complete all four sessions of the program(At 3 months ( duration of the program))
  • Change in quality of life as assessed with the PDQ-39 scale(between baseline and 6 months after baseline)
  • Change in Motor symptoms as assessed with the MDS-UPDRS-3(between baseline and 6 months after baseline)
  • Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)(between baseline and 6 months after baseline)
  • Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)(between baseline and 6 months after baseline)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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