- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07658469
Moderate-Intensity Aerobic Calisthenics for Rural Elderly With Motoric Cognitive Risk Syndrome
A Study on the Application of Moderate-Intensity Aerobic Calisthenics in Rural Elderly With Motoric Cognitive Risk Syndrome
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tuantuan Guo
- 전화번호: +86 159 5989 7344
- 이메일: 390977233@qq.com
연구 장소
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Fujian
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Fuzhou, Fujian, 중국, 350100
- Fujian Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
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.
Exclusion Criteria:
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Moderate-intensity aerobic exercise
The group was intervened with a moderate-intensity aerobic exercise program developed by the research team.
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Based on routine health education, the intervention group receives a 12-week moderate-intensity aerobic exercise intervention (Jiamusi Happy Dance Steps) lasting 60 minutes per session, three times per week, delivered in a group setting, followed by a 12-week follow-up period.
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실험적: Routine Care
This group of elderly people maintained their daily routines and received health education.
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While maintaining daily living habits unchanged, provide knowledge related to health education for Motor Cognitive Risk Syndrome (MCR) and receive the MCR health education manual.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Montreal Cognitive Assessment Basic
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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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
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Walking speed
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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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.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Cognitive Decline-questionnaire 9
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The SCD-Q9 was adapted and revised into Chinese by Hao Lixiao et al.
It encompasses two dimensions: global memory ability with time comparison, and activities of daily living.
It primarily assesses memory, recall ability, language ability, attention, orientation, and other domains.
The questionnaire consists of 9 items.
The scoring reference criteria for item responses are as follows: "Yes" = 1 point, "No" = 0 points, "Often" = 1 point, "Occasionally" = 0.5 points.
The total score ranges from 0 to 9 points, with higher scores indicating a greater likelihood of cognitive impairment.
A score of ≥5 points suggests the possible presence of potential memory impairment.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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short physical performance battery
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The Short Physical Performance Battery (SPPB), developed by the National Institute on Aging (NIH), objectively assesses balance, lower limb strength, and physical function in older adults.
Originally designed to predict disability, institutionalization, or mortality, it is now widely used for frailty, fall risk, and disease-related functional impairment.
The SPPB includes three tests: balance, 4-meter gait speed, and five-repetition sit-to-stand, each scored 0-4, total 0-12 (higher = better function).
Scores 0-3: severe mobility limitation with daily living difficulties; 4-6: mild limitation, needing assistance or aids; 7-9: normal mobility, independent in daily activities; 10-12: excellent mobility, robust and strong.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Handgrip strength
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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A electronic hand dynamometer (CAMRY, USA) was used to assess the upper limb muscle strength of the participants.
Before measurement, the staff adjusted the dynamometer to zero.
During the test, the participant stood in a natural posture with both arms hanging naturally at the sides.
The dynamometer was kept as suspended as possible without touching the body, while maintaining the device stable.
The participant was instructed to relax and then squeeze the dynamometer forcefully with the dominant hand three times (with an interval of >15 seconds between each attempt).
The maximum value among the three attempts was recorded as the grip strength.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Body fat
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Body composition was assessed using bioelectrical impedance analysis (BIA) with an InBody H20N body fat scale, primarily measuring muscle and fat-related parameters.
Before testing, participants wore light clothing without metal accessories and removed metal items such as watches, rings, and necklaces.
During testing, participants stood barefoot on the metal electrode plates with feet shoulder-width apart, ensuring close contact of heels and forefeet with the plates.
They held the handles on both sides with arms hanging naturally, hands dry and not touching the trunk.
The operator initiated the measurement, during which participants remained still, silent, and motionless.
The measurement lasted 1-2 minutes, and the device introduced a low-intensity electrical current to determine bioelectrical impedance parameters and estimate body composition.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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12-Item Short-Form Health Survey
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The SF-12, a shortened version of the 36-Item Short-Form Health Survey (SF-36), assesses health-related quality of life.
It retains the eight dimensions of the SF-36 with 12 items, covering general health (GH), physical functioning (PF), role physical (RP), bodily pain (BP), role emotional (RE), mental health (MH), vitality (VT), and social functioning (SF).
The first four dimensions evaluate physical component summary (PCS), and the latter four evaluate mental component summary (MCS).
The total score ranges from 0 to 100, with higher scores indicating better quality of life.
Xiao Huimin et al. demonstrated good reliability and validity of the SF-12 among Chinese older adults.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Patient Health Questionnaire-9
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The 9-item Patient Health Questionnaire (PHQ-9) assesses depressive symptom severity over the past two weeks.
Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), with a total score ranging from 0 to 27 (higher scores indicate greater depression severity).
Cutoff scores: 0-4 = no depression; 5-9 = possible mild depression; 10-14 = moderate depression risk; ≥15 = severe depressive symptoms.
The scale has good internal consistency (Cronbach's α = 0.894).
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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Generalized Anxiety Disorder-7 item
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The 7-item Generalized Anxiety Disorder scale (GAD-7) assesses the severity of anxiety symptoms over the past two weeks.
Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day), with a total score ranging from 0 to 21 (higher scores indicate greater anxiety severity).
Cutoff scores: 0-4 = no anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; ≥15 = severe anxiety.
The scale has good internal consistency (Cronbach's α = 0.840) and demonstrates good reliability and validity in the Chinese population.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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World Health Organization Well-being Index
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The WHO-5 Well-Being Index, developed by Bech and revised by the WHO Collaborating Centre for Research in Mental Health, assesses subjective well-being over the past two weeks.
The scale consists of 5 items, each rated on a 6-point scale (0 = none, 1 = a little of the time, 2 = less than half the time, 3 = more than half the time, 4 = most of the time, 5 = all the time).
The raw sum is multiplied by 4 to obtain a standardized total score ranging from 0 to 100, with higher scores indicating better well-being.
The scale has good internal consistency (Cronbach's α = 0.86) .
A score below 50 indicates reduced well-being [144].
In this study, well-being is categorized as high (≥70), moderate (50-70), and low (≤50).
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The Theory of Planned Behavior Questionnaire (Exercise Version)
기간: The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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The Theory of Planned Behavior Questionnaire, developed by Icek Ajzen, consists of 12 items across four dimensions: behavioral attitude, subjective norm, perceived behavioral control, and behavioral intention.
It is used to measure the social cognitive variables of the theory of planned behavior.
The target behavior in this questionnaire refers to the exercise goal set for rural older adults with Motor Cognitive Risk Syndrome (i.e., participating in at least 150 minutes of moderate-intensity aerobic exercise per week).
Items are rated on a 7-point Likert scale, ranging from "strongly disagree" to "strongly agree," with scores from 1 to 7. Higher scores indicate greater levels of agreement.
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The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
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QC 기준을 충족하는 마지막 업데이트 제출
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기타 연구 ID 번호
- 2026-04-27
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