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- Registre américain des essais cliniques
- Essai clinique NCT07822867
Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)
14 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
240
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Xiaoli Wang, PhD
- Numéro de téléphone: +8619526438101
- E-mail: wang18249277812@163.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Xiaoli Wang, PhD, Peking University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 septembre 2026
Achèvement primaire (Estimé)
15 octobre 2026
Achèvement de l'étude (Estimé)
15 décembre 2027
Dates d'inscription aux études
Première soumission
14 septembre 2026
Première soumission répondant aux critères de contrôle qualité
14 septembre 2026
Première publication (Réel)
16 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00001052-26132
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .