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临床试验/NCT07089654
NCT07089654已完成不适用

Development and Evaluation of a Psychomotor Rehabilitation Nursing Plan for the Older Adults With Mild Cognitive Impairment to Promote Cognitive Health

Jinzhou Medical University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Cognitive assessment

研究概览

简要总结

With the aging of the population, the number of older adults with mild cognitive impairment (MCI) has increased year by year, which has caused serious social and family burdens. At present, the existing drug treatment effect is limited. Studies show the application value of non-drug treatment in the older adults with mild cognitive impairment. Psychomotor Therapy (PMT) is now widely used in European countries and has formed an independent scientific system. Therefore, this topic pays attention to older adults with mild cognitive impairment, intending to promote cognitive stimulation, using PMT methods to build a rehabilitation nursing plan. Relying on older adults care institutions, older adults with mild cognitive impairment in a certain period were divided into a control group (CG) and an experimental group (EG). Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving relaxation and breathing exercises, face exercises, hand exercises, and mind exercises to promote cognitive health. SPSS 28.0 software was used to analyze data. The comparison of scores of various scales are based on paired t-test statistical methods. The P value <0.05 will be considered to indicate statistically significant with 95% confidence interval (CI). The rehabilitation effect of the two groups was evaluated according to cognitive assessments (Montreal Cognitive Assessment, MoCA), psychological assessment (Positive and Negative Syndrome Scale, PANSS), and emotional assessment (Hamilton Depression Rating Scale, HAMD-17; Hamilton Anxiety Rating Scale, HAMA-14) . The expected findings of this study may be useful for cognitive rehabilitation plans for the elderly in care institutions, rehabilitation hospitals, communities, and families.

详细描述

Introduction Research background In the wake of demographic shifts, China is experiencing the profound effects of an aging population. In 2022, China's population aged 65 and over was estimated to be 196 million, accounting for nearly 13.7% of the total population. With the change in population structure, China faces unprecedented challenges in health care, social welfare, and economic sustainability, which has a profound impact on the aging of the population, and cognitive impairment has become the most prominent problem in an aging society. Studies have shown that the overall prevalence of cognitive impairment in people aged 60 years and above in China is estimated to be 6% (95% CI: 5.8% ~ 6.3%), which increases the pressure on families, caregivers, and the healthcare system, and poses economic challenges to the country.

Similarly, population aging is a general trend around the world. According to the United Nations, by 2050, 1/6 of people in the world will be over 65 years old, compared to 1/11 in 2019. As the number of elderly people increases year by year, the prevalence of cognitive impairment in older adults is also increasing. It is reported that about 5-10% of people over 60 years old in the world suffer from dementia. Dementia is a disease characterized by cognitive decline with memory loss and impaired judgment. It not only affects the quality of life but also puts tremendous pressure on the world's healthcare systems and social support systems. Effective intervention measures are urgently needed to address this public health problem.

Mild Cognitive Impairment (MCI) refers to the prodromal stage of dementia that generally does not severely affect daily functioning, associated with an increased risk for Alzheimer's disease and other dementia. The clinical manifestations of MCI mainly include the decline of memory, language function, attention, executive function, visual-spatial structural function, and calculation ability, as well as sensory impairment and thinking disorder. While not all individuals with MCI will develop dementia. Studies have shown that MCI patients have a much higher risk of developing dementia than people with normal cognition. Early identification and intervention of MCI patients can slow or prevent the progression of dementia, thereby reducing the personal, social, and economic burden of dementia.

In recent years, there has been a large amount of literature in China that explores various aspects of dementia, including risk factors, biomarkers, diagnostic criteria, and intervention strategies. However, there are still some limitations for MCI. The diagnostic criteria and assessment tools for MCI in the Chinese population are still not unified, resulting in differences in prevalence estimates and diagnostic methods in different studies. In addition, there are insufficient longitudinal studies on the progression of MCI to dementia in older adults in China, which limits our exploration of the trajectory of the disease. Similarly, there is still no consensus on the heterogeneity of the MCI population, inconsistent diagnostic criteria, and the best treatment methods. Furthermore, the translation of research findings into clinical practice remains a significant bottleneck, with few evidence-based interventions available for preventing or delaying the onset of dementia among individuals with MCI.

Alzheimer's Disease International has advocated for and funded several studies, including some investigating the effectiveness of pharmacological and non-pharmacological interventions for early dementia. There is a great deal of ongoing research into pharmacological treatments, but traditionally, less research has been done into non-pharmacological treatments. Interventions can be broadly divided into those aimed at modifying the course of the disease, those targeting the cause of the disease, and those controlling the manifestations of the disease. PMT is often considered to fall into the last category because they may help slow cognitive decline, address symptoms related to psychosocially challenging behaviors, and improve quality of life.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Older adults are aged 50 years and above.
  • •Subjective cognitive complaints from the individual or caregiver.
  • •Screening for MCI using the Mini-Cog scores between 0-2 ( SN Abayomi, 2024).
  • •Basic language communication, listening, speaking, and understanding skills.
  • •Ability to provide informed consent.

排除标准

  • •Diagnosed with severe psychiatric conditions (e.g., schizophrenia, major depressive disorder).
  • •It is at the end stage of important functional organ diseases, such as malignant tumors, cardiac failure, etc.
  • •Limb dysfunction.
  • •Diagnosed with dementia.

研究组 & 干预措施

A PMT rehabilitation nursing plan

Experimental

Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving 2 phases of relaxation and breathing exercises, face exercises, hand exercises and mind exercises to promote cognitive health.

干预措施: A PMT rehabilitation nursing plan (Behavioral)

General rehabilitation nursing

Other

The control group will be given a standard health education on cognitive health.

干预措施: General rehabilitation nursing (Behavioral)

结局指标

主要结局

Cognitive assessment

时间窗: From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.

The cognitive status of older adults will be assessed by the Montreal Cognitive Assessment (MoCA) scale. Developed by Nasreddine et al. in Canada with reference to the MMSE, the MoCA evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation, making it suitable for a comprehensive assessment of various types of cognitive impairment. The Montreal Cognitive Assessment (MoCA) scale has a minimum score of 0 and a maximum score of 30, with higher scores indicating better cognitive function (e.g., scores near 30 reflect normal cognition), while lower scores suggest greater cognitive impairment. In Western countries, a cutoff score of 26 is commonly used to identify MCI.The results below 26 typically warrant clinical concern, though individuals with ≤12 years of education often receive a +1 point adjustment to their total score.

次要结局

  • Emotional assessment(From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.)
  • Psychological assessment(From baseline (pre-intervention) to the end of the intervention (after-intervention) at 12 weeks.)

研究者

发起方
Jinzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Ying

Lecture

Jinzhou Medical University

研究点 (2)

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