Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Step Length during Dual task gait
研究概览
简要总结
The main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (Physiocognitive Integration) in people with mild/moderate cognitive impairment.
详细描述
Alzheimer's disease and other dementias are the main cause of cognitive impairment, with a prevalence of 0.4% worldwide and 1.23 in Europe. The WHO estimates that the growth of people with cognitive impairment to some degree will increase in the coming years, exceeding 75 million people in the world in 2030, and 135 million in 2050. The prevention of cognitive deterioration is mainly based on the implementation of non-pharmacological therapies. Multisensory stimulation is a non-pharmacological therapy that has benefits in patients with cognitive impairment, producing an improvement in cognitive function.
Physical exercise is associated with a lower risk of onset of cognitive impairment and less cognitive impairment as well as a slower progression in people with mild cognitive impairment and in mild-stage dementias. In addition to the cognitive sphere, the positive effect of physical exercise in preventing falls has been widely studied.
The main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (Physiocognitive Integration) in people with mild/moderate cognitive impairment. In order to do this, a experimental group will perform 20 sessions of multisensory training in addition to their current therapy and a second, control group, only their current therapy. Before and after the time need to complete the 20 sessions, all subjects were perform a battery of motor and cognitive tasks.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).
- •In the case of subjects who are part of the intervention group, the following will also be inclusion criteria:
- •Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.
- •Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.
排除标准
- •Insufficient physical condition for participation.
- •Sensory deficits that make participation difficult.
- •Unstable clinical situation.
- •Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).
- •Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation.
结局指标
主要结局
Step Length during Dual task gait
时间窗: at week 8
Variables: Step Length (m)
Cadence of Gait at preferred pace
时间窗: at week 8
Variables: cadence (steps/min)
Speed during Dual task gait
时间窗: at week 8
Variables: Speed (m/s)
Speed of Gait at preferred pace
时间窗: at week 8
Variables: Speed (m/s)
Step Length of Gait at preferred pace
时间窗: at week 8
Variables: Step Length (m)
Cadence during Dual task gait
时间窗: at week 8
Variables: cadence (steps/min)
Time up & go test
时间窗: at week 8
Variables: time (seconds)
次要结局
未报告次要终点
研究者
Miguel Fernández del Olmo
Proffessor
Universidad Rey Juan Carlos