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

NCT07628686 | Not Yet Recruiting

• 1 other identifier: COMPETE2030-FEDER-00892100
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Cognitive Decline

Keywords

Aging; Cognitive stimulation; Physical activity; Financial and Digital literacy

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  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)

  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.

Secondary Outcomes (26)

• d2 Test

  Baseline, post-intervention (12 months), and 6-month follow-up.

• INECO Frontal Screening (IFS)

  Baseline, post-intervention (12 months), and 6-month follow-up.

• Stroop Test

  Baseline, post-intervention (12 months), and 6-month follow-up.

• Trail Making Test (TMT)

  Baseline, post-intervention (12 months), and 6-month follow-up.

• Spatial Span Subtest of the Wechsler Memory Scale - Third Edition (WMS-III)

  Baseline, post-intervention (12 months), and 6-month follow-up.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Combination Product: EMBRACE Intervention

Control Group

NO INTERVENTION

60 participants in the control group will not undergo the EMBRACE intervention; they will only receive regular health advice.

Interventions

EMBRACE Intervention COMBINATION_PRODUCT

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.

Experimental Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Fernando Pessoa: lead

Study Sites (1)

University Fernando Pessoa

Porto, Porto District, 4249-004, Portugal

Location

Related Publications (30)

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)