跳至主要内容
临床试验/NCT07658469
NCT07658469尚未招募不适用

A Study on the Application of Moderate-Intensity Aerobic Calisthenics in Rural Elderly With Motoric Cognitive Risk Syndrome

Fujian Provincial Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
Montreal Cognitive Assessment Basic

研究概览

简要总结

The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of opportunity" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.

详细描述

Motor Cognitive Risk Syndrome (MCR), first defined by Verghese et al. in 2013, refers to the coexistence of subjective cognitive decline and slow gait in older adults without dementia or movement disorders, representing a novel pre-dementia syndrome situated between normal aging and dementia. The global prevalence of MCR is 9.0% (range: 2.4%-33.3%) , and the prevalence among Chinese older adults ranges from 4.00% to 13.85% , with higher rates in rural than urban areas-reaching as high as 16.7% in rural Anhui Province. MCR significantly increases the risk of dementia (three-fold) and particularly vascular dementia (12-fold) , and also elevates the incidence of falls, disability, and mortality. Cohort studies have shown that 22.1% of individuals with MCR progress to dementia, 57.5% remain in the MCR state, and 20.3% revert to normal cognition. This reversibility suggests that MCR represents a critical window for the ultra-early prevention and treatment of dementia.

Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is a form of moderate-intensity aerobic exercise. Evidence indicates that it effectively improves cognitive and physical function in older adults, exerts superior cognitive benefits compared to other exercise types, and reduces loneliness and depressive symptoms. The participation rate in physical exercise among older adults in rural China is only 33.9%-48.29%, limited by objective constraints such as lack of facilities and equipment, and monotonous forms of exercise. Aerobic calisthenics, characterized by its economy, simplicity, high appeal, and safety, is well-suited for promotion in rural areas. However, no studies to date have reported the application effects of this intervention in the MCR population, and thus investigating its intervention value in rural older adults with MCR holds significant research importance.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥60 years;
  • Meeting the diagnostic criteria for Motor Cognitive Risk Syndrome (MCR);
  • Clear consciousness and ability to communicate clearly;
  • Permanent residents of rural areas in nine prefecture-level cities of Fujian Province (with an annual residence of ≥9 months) and no plan to relocate within the next year; -⑤ Willing to voluntarily participate and sign the informed consent form.

排除标准

  • Presence of severe mental disorders, history of stroke, Parkinson's disease, or severe visual/auditory impairments;
  • Physical disability that prevents independent walking;
  • Comorbid severe systemic diseases, such as cardiopulmonary conditions; -④ Regular exercise habits within the past 6 months (≥30 minutes/day, ≥3 days/week) or a long-term history of exercise; -⑤ Current participation in other interventional studies.

研究组 & 干预措施

Moderate-intensity aerobic exercise

Experimental

The group was intervened with a moderate-intensity aerobic exercise program developed by the research team.

干预措施: moderate-intensity aerobic exercise (Other)

Routine Care

Experimental

This group of elderly people maintained their daily routines and received health education.

干预措施: Routine Care (Other)

结局指标

主要结局

Montreal Cognitive Assessment Basic

时间窗: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

The MoCA-B was jointly developed by the Montreal Cognitive Assessment Clinic and Research Institute in Canada, in collaboration with the Prince Mahidol Award Foundation of Thailand and the Faculty of Medicine at Chulalongkorn University. It has a total score of 30 points and encompasses eight cognitive domains: executive function, language, orientation, calculation, abstract thinking, memory, visual perception, and attention, with higher scores indicating better cognitive function. The cutoff values are as follows: for years of education ≤6 years, MoCA-B ≥20; for 6 years \< years of education ≤12 years, MoCA-B ≥23; and for years of education \>12 years, MoCA-B ≥25. The scale correctly identifies cognitively normal participants with a specificity of 86%, and demonstrates a sensitivity of 81% for detecting cognitive impairment. The Cronbach's α coefficient of the scale is 0.807, and the criterion valid

Walking speed

时间窗: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

The timed walking test was used to measure gait speed. The required equipment included a tape measure and a stopwatch. The specific procedure was as follows: First, a straight 6-meter course was measured using the tape measure, and the middle 4-meter segment was marked. The participant stood at the starting point. Then, upon the tester's command "Start," the participant walked at their normal pace to the endpoint. The time taken to cover the middle 4 meters was recorded using the same stopwatch. This was performed twice. Finally, gait speed was calculated using the formula speed = distance / time, with the average time of the two trials used for calculation.

次要结局

  • Subjective Cognitive Decline-questionnaire 9(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • short physical performance battery(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • Handgrip strength(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • Body fat(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • 12-Item Short-Form Health Survey(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • Patient Health Questionnaire-9(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • Generalized Anxiety Disorder-7 item(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • World Health Organization Well-being Index(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)
  • The Theory of Planned Behavior Questionnaire (Exercise Version)(The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuanjiao Yan

Study Director

Fujian Medical University

研究点 (1)

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