- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07822867
Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)
2026년 9월 14일 업데이트: Peking University
This multicenter randomized controlled trial aims to evaluate the effects of a Baduanjin-based exercise snacking intervention on cognitive function in older adults with mild cognitive impairment (MCI).
A total of 240 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group.
The control group will receive routine health education, while the intervention group will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The exercise program consists of short bouts of Baduanjin practice distributed throughout the day to facilitate integration into daily life.
Assessments will be conducted at baseline and at weeks 12, 24, and 48.
The primary outcome is global cognitive function.
Secondary outcomes include specific cognitive domains, physical function, emotional status, sleep, and other health-related measures.
Exercise adherence, physical activity, and safety will also be evaluated.
연구 개요
연구 유형
중재적
등록 (추정된)
240
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xiaoli Wang, PhD
- 전화번호: +8619526438101
- 이메일: wang18249277812@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Aged 51 to 80 years, inclusive.
Meet the NIA-AA core clinical criteria for probable amnestic mild cognitive impairment (aMCI), including all of the following:
- A self-reported and/or informant-reported history of progressive memory decline lasting for more than 6 months, confirmed by a study neurologist;
- Objective impairment in one or two cognitive domains on standardized neuropsychological testing, with memory impairment required;
- Montreal Cognitive Assessment (MoCA) score of 18-26;
- Cognitive impairment does not result in significant functional dependence, with instrumental activities of daily living (IADL) remaining normal or only mildly impaired;
- Does not meet diagnostic criteria for any type of dementia.
- Able to independently use a smartphone and complete online check-ins, questionnaires, and other digital assessment tasks.
- Able to walk independently without assistance.
- No absolute contraindications to exercise, as determined by the Physical Activity Readiness Questionnaire or by a study physician when exercise-related risks are considered manageable.
- Willing and able to provide written informed consent.
- A primary caregiver, if applicable, is informed of and supportive of study participation.
- Willing and able to comply with the 24-month follow-up schedule and complete all study assessments and intervention tasks.
- Participants taking cognition-enhancing or other cognition-active medications may be included, provided that the medication dose has remained stable for at least 1 month before screening.
Exclusion Criteria:
Cognitive impairment attributable to other causes, including:
- Meeting clinical diagnostic criteria for Alzheimer's disease or another type of dementia;
- Cognitive impairment primarily attributable to another clearly identified condition, including neurodegenerative diseases (e.g., Parkinson's disease, Huntington's disease, progressive supranuclear palsy, or multiple sclerosis), severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, or major depressive episode with psychotic features), or systemic diseases (e.g., uncontrolled thyroid dysfunction or vitamin B12 deficiency).
Severe or unstable medical conditions, including any of the following:
- Acute cardiovascular or cerebrovascular event within the previous 6 months, including myocardial infarction, unstable angina, stroke, or transient ischemic attack;
- New York Heart Association (NYHA) class III or IV heart failure;
- Poorly controlled hypertension, defined as resting blood pressure ≥180/110 mmHg;
- Poorly controlled diabetes mellitus, defined as HbA1c >9.0%;
- Severe musculoskeletal disease resulting in inability to walk continuously for more than 100 meters;
- Severe respiratory disease;
- Malignancy with an estimated life expectancy of less than 2 years.
- Severe visual or hearing impairment that prevents the participant from adequately seeing assessment materials or hearing instructions despite the use of conventional corrective devices, such as glasses or hearing aids.
High risk of falls, defined by any of the following:
- Two or more unprovoked falls during the previous year;
- A score of 0 on the balance component of the Short Physical Performance Battery (SPPB), indicating inability to stand with the feet together;
- Requirement for routine use of a walking aid or wheelchair.
- Current participation in another clinical trial that may affect cognitive function or physical activity.
- Planning to relocate outside the study area for more than 3 months during the next 24 months.
- Any other condition that, in the investigator's judgment, may compromise participant safety, data integrity, or adherence to the study protocol.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Baduanjin Exercise Snacking Group
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief, repeated bouts of Baduanjin exercise performed multiple times throughout the day.
Standardized instructional videos and digital support will be provided to facilitate intervention delivery and adherence.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
|
활성 비교기: Control Group
Participants will receive routine health education during the 24-week intervention period and will not receive the prescribed Baduanjin-based exercise snacking intervention.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
기간: Baseline and Week 24
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The primary outcome is the change in MoCA score from baseline to Week 24.
|
Baseline and Week 24
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12
기간: Baseline and Week 12
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The outcome is the change in MoCA score from baseline to Week 12.
|
Baseline and Week 12
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Xiaoli Wang, PhD, Peking University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 15일
기본 완료 (추정된)
2026년 10월 15일
연구 완료 (추정된)
2027년 12월 15일
연구 등록 날짜
최초 제출
2026년 9월 14일
QC 기준을 충족하는 최초 제출
2026년 9월 14일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .