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EMBRACE - From Vulnerable to Empowered: Implementation and Evaluation of a Multicomponent Program to Tackling Age-related Decline (EMBRACE)

2 de junio de 2026 actualizado por: Carina Fernandes, University Fernando Pessoa
EMBRACE is a randomized, controlled, multi-domain, blinded clinical trial involving 120 community-dwelling older adults at risk of cognitive decline, lasting 12 months. Participants are randomized 1:1 to either a multicomponent intervention group, including cognitive and language training, physical activity, nutritional counseling with oral health support, and financial and digital literacy education, or to a control group receiving regular health counseling. The trial evaluates the effects of the intervention on cognitive performance, quality of life, functionality, financial literacy, digital inclusion, and other health-related outcomes.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The EMBRACE program is a research initiative designed to address the increasing challenges of aging, particularly the risk of cognitive decline and dementia, vulnerability to economic fraud, and digital exclusion. The EMBRACE intervention is a multicomponent, non-pharmacological approach that includes cognitive training, linguistic stimulation, physical activity guidance, nutritional counseling, and education on financial and digital literacy. Through a carefully designed randomized controlled trial, this research project aims to evaluate the effectiveness of the EMBRACE program in improving the quality of life, functionality, and overall well-being of older adults.

By combining various aspects of health and well-being, the project aligns with the emphasis of the World Health Organization (WHO) on developing and implementing preventive strategies to reduce the risk of dementia. The innovative aspect of integrating financial and digital literacy education into the intervention recognizes the evolving challenges faced by the aging population, who are among the primary victims of economic fraud and particularly vulnerable to digital exclusion.

The primary beneficiaries of the EMBRACE program will be older adults who are at risk of developing cognitive decline or dementia. By equipping participants with tools and strategies to maintain cognitive health and physical well-being, the project aims to enhance quality of life. Moreover, the program's findings could inform public health policies and eldercare practices, potentially benefiting a broader spectrum of older adults by promoting strategies for active and healthy aging. In addition to direct participants, the project's outcomes are expected to benefit healthcare professionals, caregivers, and policymakers by providing validated approaches to prevent or delay cognitive decline among older adults. Furthermore, if the EMBRACE program proves successful, the investigators plan to integrate it into the curriculum of national senior universities and adapt it for digital platforms. This would enable global dissemination, extending its benefits to a broader audience worldwide.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

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

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4249-004
        • University Fernando Pessoa
        • Contacto:

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
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • MoCA ≥ 17 (Portuguese cutoff point to differentiate between mild cognitive impairment and dementia);
  • Bedside ≥ 20 for literate individuals or 12 for illiterate individuals.

Exclusion Criteria:

  • Malignant diseases;
  • Diagnosed major depressive disorder;
  • Dementia/substantial cognitive decline (MoCA < 17);
  • Symptomatic cardiovascular disease;
  • Revascularization within the last year;
  • Active malignancy;
  • Severe loss of vision, hearing, or communication;
  • Contraindications for physical activity;
  • Neuromuscular diseases;
  • Severe musculoskeletal pathology;
  • Inability to walk independently;
  • Neurological disease affecting language functions;
  • Simultaneous participation in any intervention trial.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental Group
60 participants in the experimental group (EG) will receive an intensive multicomponent intervention consisting of nutrition and oral medicine; physical activity; cognitive training (or compensation in those cases in which participants revealed mild cognitive impairment at the baseline assessment); and financial and digital literacy education.
Producto combinado: EMBRACE Intervention
This intervention will last 12 months and will consist of four components. The nutritional intervention includes 5 individual sessions (at the beginning of the study and at 3, 6, 9, and 12 months) and 12 group sessions (1 per month) based on the Mediterranean diet, with support for oral health. Financial and digital literacy will be addressed in monthly sessions, covering topics such as retirement, investments, and fraud prevention. Cognitive and linguistic training will take place twice a week (80 sessions), with activities adapted through the COGWEB platform and support from a speech therapist. Physical training will also be conducted twice a week, including aerobic exercise, strength training, balance training, and dual-task training, with intensity adjusted using the Borg scale.
Sin intervención: Control Group
60 participants in the control group will not undergo the EMBRACE intervention; they will only receive regular health advice.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
General cognitive functions will be assessed using the MoCA. The MoCA is a cognitive screening instrument used to evaluate multiple cognitive domains, with scores ranging from 0 to 30, where higher scores indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Quality of life will be assessed using the WHOQOL-BREF. The WHOQOL-BREF is a questionnaire used to evaluate quality of life across physical, psychological, social relationships, and environmental domains, with scores ranging from 0 to 100, where higher scores indicate better quality of life.
Baseline, post-intervention (12 months), and 6-month follow-up.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
d2 Test
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Selective attention and concentration ability will be assessed using the d2 Test. The d2 Test is a neuropsychological instrument used to evaluate selective attention, concentration, and processing speed through a timed cancellation task consisting of 14 lines to be completed in a maximum of 20 seconds per line. Performance is measured through task execution indices, concentration, processing speed, and error percentage. Higher scores on task execution and concentration indices, and lower error percentages, indicate better attentional performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
INECO Frontal Screening (IFS)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Executive functions will be assessed using the IFS. The IFS is a cognitive screening instrument used to evaluate executive functioning, including inhibitory control, cognitive flexibility, working memory, and abstraction ability, with scores ranging from 0 to 30, where higher scores indicate better executive functioning.
Baseline, post-intervention (12 months), and 6-month follow-up.
Stroop Test
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Inhibitory control, cognitive flexibility, and resistance to interference will be assessed using the Stroop Test. The Stroop Test consists of three tasks (word, color, and color-word), each administered within a maximum time of 45 seconds. Performance is measured by the number of words, colors, and stimuli correctly identified, where higher scores indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Trail Making Test (TMT)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Alternating attention, visual attention, and processing speed will be assessed using the TMT. The TMT is a neuropsychological instrument used to evaluate visual attention, alternating attention, and processing speed through a timed task requiring participants to connect a sequence of numbers and letters. Performance is measured by completion time in seconds, where shorter completion times indicate better cognitive performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Spatial Span Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Working memory will be assessed using the Spatial Span Subtest of the WMS-III. The Spatial Span Subtest is a neuropsychological instrument used to evaluate visuospatial working memory through forward and backward span tasks, with scores ranging from 0 to 32, where higher scores indicate better working memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Logical Memory Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Immediate and delayed verbal episodic memory will be assessed using the Logical Memory Subtest of the WMS-III. The Logical Memory Subtest is a neuropsychological instrument used to evaluate the recall and recognition of verbally presented information, with scores ranging from 0 to 75 for immediate recall, 0 to 30 for delayed recall, and 0 to 30 for recognition, where higher scores indicate better memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Rey Auditory Verbal Learning Test (RAVLT)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Verbal learning and memory will be assessed using the RAVLT. The RAVLT is a neuropsychological instrument used to evaluate verbal learning, immediate recall, delayed recall, and recognition memory through repeated presentation of a 15-word list. Performance is measured by the number of correctly recalled or recognized words across the assessment trials, where higher scores indicate better verbal learning and memory performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Boston Naming Test (BNT)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Naming ability will be assessed using the BNT. The BNT is a neuropsychological instrument used to evaluate confrontation naming ability through the identification of visually presented objects, with scores ranging from 0 to 60, where higher scores indicate better naming performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Phonemic and Semantic Verbal Fluency Tests
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Verbal fluency and executive functions will be assessed through Phonemic and Semantic Verbal Fluency Tests. These neuropsychological tests are used to evaluate information retrieval from memory, executive functions (such as cognitive flexibility, planning, and inhibitory control), and language production through word generation within a maximum time frame of 1 minute for each task, where higher scores indicate better performance in verbal fluency.
Baseline, post-intervention (12 months), and 6-month follow-up.
Instrumental Activities of Daily Living (IADL)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Functionality in instrumental activities of daily living will be assessed using the IADL scale. The IADL scale is used to evaluate independence in everyday functional activities, with scores ranging from 8 to 31, where lower scores indicate greater functional independence.
Baseline, post-intervention (12 months), and 6-month follow-up.
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Symptoms of anxiety and depression will be assessed using the HADS. The HADS is a self-report questionnaire used to evaluate symptoms of anxiety and depression, with scores ranging from 0 to 21 for each subscale, where higher scores indicate greater symptom severity.
Baseline, post-intervention (12 months), and 6-month follow-up.
Numerical Activities of Daily Living - Financial (NADL-F)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Financial literacy and functionality in numerical activities of daily living will be assessed using the NADL-F assessment. The NADL-F is used to evaluate financial abilities and numerical functioning in everyday activities across domains including money counting (scores ranging from 0 to 5), reading abilities (0 to 8), purchasing articles (0 to 14), percentages (0 to 9), financial concepts (0 to 14), bill payment (0 to 6), and financial judgment (0 to 6), where higher scores indicate better financial functioning and autonomy in daily life.
Baseline, post-intervention (12 months), and 6-month follow-up.
Bedside Language Test
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Language abilities will be assessed using the Bedside Language Test. The Bedside Language Test is a language assessment tool used to evaluate speech, language comprehension, repetition, reading, and writing abilities, with scores ranging from 0 to 25, where higher scores indicate better language performance.
Baseline, post-intervention (12 months), and 6-month follow-up.
PREDIMED
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Adherence to the Mediterranean diet will be assessed using the PREDIMED questionnaire. The PREDIMED questionnaire is used to evaluate adherence to Mediterranean dietary patterns, with scores ranging from 0 to 14, where higher scores indicate greater adherence to the Mediterranean diet.
Baseline, post-intervention (12 months), and 6-month follow-up.
International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Physical activity level will be assessed using the IPAQ. The IPAQ is used to evaluate the frequency, duration, and intensity of physical activity performed in daily life. Physical activity levels are calculated in MET-minutes per week based on the frequency and duration of walking and moderate- and vigorous-intensity activities, with higher scores indicating higher levels of physical activity.
Baseline, post-intervention (12 months), and 6-month follow-up.
Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Functional mobility and dynamic balance ability will be assessed using the TUG. The TUG is used to evaluate functional mobility and dynamic balance through the time required to stand up from a chair, walk a short distance, return, and sit down, with performance measured in seconds, where shorter completion times indicate better functional mobility and balance.
Baseline, post-intervention (12 months), and 6-month follow-up.
Blood Pressure
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg). Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Baseline, post-intervention (12 months), and 6-month follow-up
Body Mass Index (BMI)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Body mass index (BMI) will be calculated using body weight and height and expressed in kilograms per square meter (kg/m²). BMI is a measure of body size based on weight relative to height.
Baseline, post-intervention (12 months), and 6-month follow-up
Handgrip Strength
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Handgrip strength will be assessed using a hand dynamometer. Performance is measured in kilograms-force (kgf), where higher values indicate greater muscular strength.
Baseline, post-intervention (12 months), and 6-month follow-up
Blood Count
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Hematological status will be assessed using a blood count performed through blood analysis. Results will be reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Serum Magnesium
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Serum magnesium levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Serum Iron
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Serum iron levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Vitamin B12
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up
Vitamin B12 levels will be assessed through blood analysis and reported according to standard laboratory reference units.
Baseline, post-intervention (12 months), and 6-month follow-up
Decayed, Missing, and Filled Teeth Index (CPO-D)
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Oral health status will be assessed using the Decayed, Missing, and Filled Teeth Index (CPO-D). The CPO-D index is used to evaluate oral health status based on the number of decayed, missing, and filled teeth, where higher scores indicate poorer oral health status.
Baseline, post-intervention (12 months), and 6-month follow-up.
Salivary pH Analysis
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Salivary condition and oral health status will be assessed using salivary pH analysis. Salivary pH values will be measured to evaluate salivary condition and oral health status, and will be reported according to standard pH units.
Baseline, post-intervention (12 months), and 6-month follow-up.
Dental Prosthesis Status
Periodo de tiempo: Baseline, post-intervention (12 months), and 6-month follow-up.
Dental prosthesis status will be assessed through clinical oral examination. The assessment will evaluate the presence, type, functional status, and need for adjustment or replacement of dental prostheses.
Baseline, post-intervention (12 months), and 6-month follow-up.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Fernando Pessoa

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de mayo de 2028

Finalización del estudio (Estimado)

31 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • COMPETE2030-FEDER-00892100

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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