Adapted Physical Activity Education in Patients With Neurocognitive Disorder: Single-blind, Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- physical activity level
研究概览
简要总结
This study aims to compare the effect of a program of Adapted Physical Activity (APA) versus the same program combined with a physical activity education program (PAE). Patients suffering from neurocognitive disorders (mild or early major) will be randomized into one of the two conditions. 3 complete evaluations will be done (inclusion M0, after 3 month of intervention M3, 3 months after the end of the intervention M6). The team except that APA+PEA will be more effectiv than the APA solely, on the following criteria : level of physical activity, cogntive function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild neurocognitive disorder or early major neurocognitive disorder
排除标准
- •Medical pathology involving the vital prognosis in the short term
- •Major neurocognitive disorder at moderate stage and beyond (DSM 5) and/or MMSE < 20
- •Unbalanced depressive syndrom
- •Contraindication to the practice of the exercises proposed during the study;
- •Major hearing or visual impairment;
- •Sufficiently active with regard to the daily recommendations described by the WHO
研究组 & 干预措施
APA (adapted physical activity)
24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,
干预措施: APA (Other)
APA (adapted physical activity) + physical activity education (PAE)
24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,
+ 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior
干预措施: APA (Other)
APA (adapted physical activity) + physical activity education (PAE)
24 APA sessions will take place, there will be 2 sessions a week for 12 weeks which will include global exercises for the upper and lower limb. One session will be 1 hour long and supervised by professionals. It will be divided in 4 cycles which will be differentiated by the intensity of its components: aerobic, strength, speed, balance, coordination and flexibility. The intensity of the sessions will be measured by RPE and heart rate monitor,
+ 8 individuals sessions of PAE (one per week, half an hour long) that will consist of advising and setting weekly goals related to improving PA level and sedentary behavior
干预措施: PAE (Other)
结局指标
主要结局
physical activity level
时间窗: at 6 months after inclusion
evolution of physical activity level will be assessed by actimetry on a 7 days period mesured by IPAQ score
次要结局
- executive functions(at 6 months after inclusion)
- executive functions (TMT)(at 6 months after inclusion)
- cardiovascular performance(at 6 months after inclusion)
- executive functions (FAB)(at 6 months after inclusion)
- strenght - physical condition(at 6 months after inclusion)
- global cognition(at 6 months after inclusion)
- evaluation of quality of life(at 6 months after inclusion)
- anxiety and depression(at 6 months after inclusion)
- power - physical condition(at 6 months after inclusion)
- apathy(at 6 months after inclusion)