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临床试验/NCT05685095
NCT05685095
撤回
不适用

Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson

University Hospital, Grenoble1 个研究点 分布在 1 个国家2023年2月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Parkinson Disease
发起方
University Hospital, Grenoble
试验地点
1
主要终点
Changes in daily energy expenditure
状态
撤回
最后更新
3年前

概览

简要总结

The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).

Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.

The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.

Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.

注册库
clinicaltrials.gov
开始日期
2023年2月
结束日期
2026年10月
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Grenoble
责任方
Sponsor

入排标准

入选标准

  • Parkinson's disease, diagnosed for at least 2 years,
  • Medical treatment (if any) unchanged in the past 4 weeks at least
  • Hoehn \& Yahr score \< 3
  • Montreal cognitive assessment (MOCA) score between 20 and 30
  • Able to understand the aim and methods of the study and provide signed informed consent-

排除标准

  • Atypical parkinsonian syndrome
  • Cardiovascular pathology preventing moderate physical exercise
  • Orthostatic hypotension
  • Any condition (other than PD) interfering with gait
  • pregnant or nursing

结局指标

主要结局

Changes in daily energy expenditure

时间窗: recording 7 days in a row, at 3 months, 6 months and 9 months.

Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt.

次要结局

  • Evolution of exercise functional capacity(3 months, 6 months and 9 months.)
  • Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.(3 months, 6 months and 9 months.)
  • Evolution over time of the Parkinsons' Disease Fatigue Scale score.(3 months, 6 months and 9 months.)
  • Evolution of gait parameters(3 months, 6 months and 9 months.)
  • Adherence to the training program(3 months)

研究点 (1)

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