Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Cognitive Function
研究概览
简要总结
This is a prospective study. The aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease.
There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).
详细描述
this is a 12-week prospective study with the theme that I wish to develop in this context entitled "the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease".
There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).
The recruited subjects will be randomly assigned to two groups: a control group and an experimental group. The subjects will be invited to attend the program three times per week.
The control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program
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
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria.
- •Mild to moderate stage according to the Hoehn and Yahr scale.
- •No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol.
- •Has the ability to communicate and walk.
- •Patient has been stable on treatment for 3 months.
排除标准
- •A contraindication to engaging in cardiovascular physical activity
- •A Montreal Cognitive Assessment score (MoCA ) of less than
- •A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol.
- •Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program.
- •Treatment with sedative medications
结局指标
主要结局
Cognitive Function
时间窗: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .
Cardiorespiratory Parameters
时间窗: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).
Postural Balance
时间窗: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform
Depression
时间窗: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
The depression variable will be assessed through Beck Depression Inventory-II .
次要结局
- Strength(There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient))
研究者
Ghazoua Nafti
Principal Investigator Ghazoua NAFTI
Faculty of Medicine, Sousse