NCT07146373招募中不适用
The Effect of Strengthening Respiratory Muscles on Cognitive and Physical Functioning in Patients With Neurocognitive Disorders
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Mini Mental State Examination
研究概览
简要总结
The goal of this clinical trial is to examine the effect of a respiratory muscle strengthening program on the cognitive and physical functioning of patients with neurocognitive disorders (Mild Cognitive Impairment) or those predisposed to them.
The main questions that aims to answer are:
- Is Inpsiratory Muscle Training (IMT) feasible in people with mild cognitive impairement?
- Could Inspiratory Muscle Training (IMT) improve congitive function in people with mild cognitive impairement?
- Could Inspiratory Musclre training improve physical function in this population?
Participants will be:
- < 60 age or > 90 age
- MMSE (Mini Mental State Examination) score ≤ 28 and ≥ 18 and follow a high intensity IMT program along with a physical - cognitive program. or just the physical - cognitive program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MMSE (Mini Mental State Examination) score ≤ 28 και ≥ 18
- •stable treatment related to medication
排除标准
- •MMSE score < 18 και > 28
- •psychological disorder
- •any contraindication to physical training
研究组 & 干预措施
Control
Active Comparator
Physical and cognitive training
干预措施: Usual Care (Other)
Inspiratory Muscle Training
Experimental
IMT that consists of 5set/6 breaths at 50-60% of Maximal Inspiratory Pressure, 5 session per weak for 3 months.
Physical and Cognitive training
干预措施: Inspiratoty Muscle training (Other)
结局指标
主要结局
Mini Mental State Examination
时间窗: T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up)
次要结局
- Frontal Assessment Battery(T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up))
- Addenbrooke's Cognitive Examination(T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up))
- Time up and Go (TUG)(T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up))
- Sit-to-Stand test(T0 at the beginning, T1 at 3 months (end of intervention), T2 at 6 months (follow-up))
研究者
IRINI PATSAKI
Assistant Professor
University of West Attica
研究点 (1)
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