ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Supervised gait performance dual task gait
研究概览
简要总结
The study will evaluate the impact of exercise training program followed by long-walking onon supervised and unsupervised gait assessment in Parkinson´s disease and control subjects.
详细描述
Background: Several studies suggest an impact of physical exercise on walking parameters in Parkinson´s disease (PD) patients.
Objective
the present study will evaluate the impact of three months physical exercise training program followed by a group-long walking on motor impairment in PD.
Methods:
PD patients will be randomized in two arms: one group will be assessed to a training exercise program of three months followed by long-walking in group under the support of physician/physiotherapist and caregivers. A complete motor, cognitive and general assessment will be performed at baseline. The patients will be evaluated under supervised an unsupervised conditions at baseline, before the long-walking, during the walking and after 2 months after the walk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson´s disease diagnosis
- •stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation)
排除标准
- •gait impairment due to other medical conditions
- •impulsive compulsive disorder
- •severe depression
结局指标
主要结局
Supervised gait performance dual task gait
时间窗: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.
Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)
unsupervised gait performance normal gait
时间窗: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.
Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)
Supervised gait performance normal gait
时间窗: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.
Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)
次要结局
- Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes(Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care.)
- Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes(Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care.)
研究者
Andrea Pilotto
Principal Investigator
Università degli Studi di Brescia