Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Changes in daily energy expenditure
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The researchers involved in data collection and in data analysis will be blinded with regard to the patients' group allocation. Randomization will be performed by an operator not otherwise involved in the study, under the RED-Cap application.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)