The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment (CMintervention)
13 mai 2026 mis à jour par: Xiaoying Wang
Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China
This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI).
The program is designed to help maintain or improve cognitive function and overall well-being.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Health education sessions: One 30-minute lecture every 4 weeks, covering topics such as diet, sleep, chronic disease management, and brain health.
Cognitive training: Weekly 45-minute sessions using fun mini-games to train memory, attention, arithmetic, and logical thinking.
Physical exercise: Weekly 45-minute sessions of traditional Chinese exercises (Baduanjin and Shiqiaoshou) to improve balance, flexibility, and fitness.
Type d'étude
Interventionnel
Inscription (Réel)
235
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.
Lieux d'étude
-
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Fujian
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Quanzhou, Fujian, Chine
- Yuxi, Gucuo, Su'an, Qianhong village
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-
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 plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age ≥ 60;
- Suffering from chronic diseases, such as hypertension, diabetes mellitus, hyperlipidemia, cardiovascular and cerebrovascular diseases, or osteoarthritis;
- Mild cognitive impairment (defined as Mini-Mental State Examination (MMSE) score of 21-26 combined with either an AD8 self-rated cognitive impairment score ≥ 2 or a digit span (backward) test (DST) score < 4);
- Mild physical impairment (defined as an Activities of Daily Living (ADL) score < 26 and a Short Physical Performance Battery (SPPB) score of 7-10).
Exclusion Criteria:
- Age <60;
- Unable to move physically;
- Already suffering from Alzheimer's disease.
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: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: CM intervention group
The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise.
The health education sessions were delivered once every four weeks, with each session lasting 30 minutes.
In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.
|
The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise.
The health education sessions were delivered once every four weeks, with each session lasting 30 minutes.
In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.
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Aucune intervention: Control group
the group that does not receive the intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive Function
Délai: From enrollment to the end of intervention at 48 weeks
|
Cognitive function was assessed using the Minimum Mental State Examination (MMSE) scale (Folstein, Folstein, & McHugh, 1975).The MMSE evaluates five domains: orientation, registration, attention and calculation, recall, and language abilities.
Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
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From enrollment to the end of intervention at 48 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body Mass Index
Délai: From enrollment to the end of intervention at 48 weeks
|
Height (cm) was measured using a wall-mounted height board, with the participant standing upright without shoes.
Weight (kg) was measured using a electronic load cell scale, with light indoor clothing and after voiding.
Body Mass Index (BMI) was calculated by dividing a person's weight in kilograms by the square of their height in meters (kg/m²).
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From enrollment to the end of intervention at 48 weeks
|
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Waist circumference
Délai: From enrollment to the end of intervention at 48 weeks
|
Waist circumference (cm) was measured using a flexible, non-elastic tape measure at the midpoint between the lowest rib and the iliac crest, with the participant standing and breathing normally.
The measurement is taken to the nearest 0.1 cm at the end of normal expiration.
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From enrollment to the end of intervention at 48 weeks
|
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Blood pressure
Délai: From enrollment to the end of intervention at 48 weeks
|
Blood pressure was assessed by measuring systolic and diastolic pressures (mmHg).
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From enrollment to the end of intervention at 48 weeks
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Activities of daily living
Délai: From enrollment to the end of intervention at 48 weeks
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Activities of daily living were assessed via the Activities of daily living (ADL) scale (Ferrucci et al., 1996).
It employs a scoring range of 14 to 56, with higher scores indicating poorer functional ability.
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From enrollment to the end of intervention at 48 weeks
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Physical performance
Délai: From enrollment to the end of intervention at 48 weeks
|
Physical performance was assessed via the Short Physical Performance Battery (SPPB) scale (Cruz-Jentoft et al., 2010).
It has a scoring range of 0 to 12, with higher scores reflecting better physical performance.
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From enrollment to the end of intervention at 48 weeks
|
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Participant adherence
Délai: From enrollment to the end of intervention at 48 weeks
|
Participant adherence was summarized as the proportion of total participants who attended at least 50% of the intervention sessions, and separately for those who attended at least 75% of the sessions.
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From enrollment to the end of intervention at 48 weeks
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Participant satisfaction
Délai: From intervention at 36 weeks to the end of intervention at 48 weeks
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Participant satisfaction was assessed using a self-developed scale, with a total score of 30 points; higher scores indicated greater satisfaction with the program.
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From intervention at 36 weeks to the end of intervention at 48 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 (Réel)
15 août 2024
Achèvement primaire (Réel)
11 octobre 2025
Achèvement de l'étude (Réel)
11 octobre 2025
Dates d'inscription aux études
Première soumission
26 avril 2026
Première soumission répondant aux critères de contrôle qualité
13 mai 2026
Première publication (Réel)
15 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- No. XDYX202411K77
- 2022YFC3603000 (Autre subvention/numéro de financement: the National Key Research and Development Program of China)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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
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