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临床试验/NCT04340492
NCT04340492
已完成
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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2021年3月15日

概览

阶段
不适用
干预措施
Education to Adapted Physical Activity
疾病 / 适应症
Parkinson Disease
发起方
University Hospital, Lille
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
状态
已完成
最后更新
前天

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.

注册库
clinicaltrials.gov
开始日期
2021年3月15日
结束日期
2025年10月28日
最后更新
前天
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Lille
责任方
Sponsor

入排标准

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

干预措施: Education to Adapted Physical Activity

control group

干预措施: Standard care

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)

研究点 (2)

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