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

NCT07628686 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-05

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

  • University Fernando Pessoa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-05-31
Completion
2029-05-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628686 on ClinicalTrials.gov