The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment (CMintervention)
13 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
235
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
Fujian
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Quanzhou, Fujian, Porcelana
- Yuxi, Gucuo, Su'an, Qianhong village
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
|
|
Sin intervención: Control group
the group that does not receive the intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cognitive Function
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Mass Index
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to the end of intervention at 48 weeks
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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
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to the end of intervention at 48 weeks
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de agosto de 2024
Finalización primaria (Actual)
11 de octubre de 2025
Finalización del estudio (Actual)
11 de octubre de 2025
Fechas de registro del estudio
Enviado por primera vez
26 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- No. XDYX202411K77
- 2022YFC3603000 (Otro número de subvención/financiamiento: the National Key Research and Development Program of China)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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