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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity Fernando Pessoa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

MoCA ≥ 17 (Portuguese cutoff point to differentiate between mild cognitive impairment and dementia);

Bedside ≥ 20 for literate individuals or 12 for illiterate individuals.

Disqualifiers

Malignant diseases;

Diagnosed major depressive disorder;

Dementia/substantial cognitive decline (MoCA < 17);

Symptomatic cardiovascular disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, post-intervention (12 months), and 6-month follow-up.
2

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.

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

Secondary outcomes

1

d2 Test

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.

Time frame
Baseline, post-intervention (12 months), and 6-month follow-up.
2

INECO Frontal Screening (IFS)

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.

Time frame
Baseline, post-intervention (12 months), and 6-month follow-up.
3

Stroop Test

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.

Time frame
Baseline, post-intervention (12 months), and 6-month follow-up.
4

Trail Making Test (TMT)

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.

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

Other outcomes

Sponsors and contacts

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