NCT05383443

MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

Multiple Interventions to Prevent Cognitive Decline (MIND-Matosinhos) - a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Instituto de Saude Publica da Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The present study aims to quantify the impact of a multidomain approach to prevent cognitive decline in individuals from the general population at-high risk of dementia. It will be based on five distinct components: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss.

Detailed description

This is a community-based randomized controlled trial (RCT), which will be implemented in Matosinhos municipality (Portugal) and will be conducted over three months, possibly extensible up to 12 months. Eligible individuals (n=300) will be randomized (1:1) into two arms: intervention and control groups. The intervention plan will be composed by five non-pharmacological strategies, namely: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss. This plan will be applied to both groups, but with lower intensity among the control group. Participants' characteristics will be assessed at baseline and at three months; for those who complete one year of intervention, additional follow-ups at six and 12 months after the beginning of the intervention will be conducted. These evaluations will cover the following domains: sociodemographic, lifestyle, health and anthropometric characteristics; cognitive function; subjective memory complains; symptoms of anxiety and depression; quality of life; physical performance; levels of glycated hemoglobin and 24-hour urinary sodium, potassium, creatinine excretion as well as pH. The results of the present study may guide future clinical practices and health policies aiming to prevent cognitive decline and reduce the overall burden of dementia.

Conditions

• Cognitive Dysfunction
• Cognition Disorder
• Memory Disorders
• Cognitive Impairment
• Neurocognitive Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive training	This component will comprise the following activities: i. In-person group training (monthly): 60-minute sessions, supervised by a psychologist; ii. Home individual training (≥5 times per week): unsupervised 30-minutes remote sessions, using the COGWEB® online platform or paper/pencil exercises (for those participants without computer/internet or who do not use one autonomously).
BEHAVIORAL	Physical exercise	This component will be based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher: i. In-person group training (monthly); ii. In-person group training or remote synchronous training (group) or provision of education booklets with photos and exercise instructions to be performed individually (twice weekly), depending on the evolution of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic.
BEHAVIORAL	Nutrition education	This component will be based on the following activities: i. In-person group 120-minute sessions (monthly), guided by a nutritionist, comprising: presentation and discussion of healthy and easy to cook recipes by the nutritionist and preparation of healthy meals by the participants; ii. In-person individual appointment with a nutritionist (monthly).
BEHAVIORAL	Capacitation to deal with cognitive decline	This component will be based on in-person 60-minute group sessions (monthly), guided by a psychologist, allowing participants to share experiences and learn strategies to cope with cognitive decline in their daily life.
OTHER	Diagnosis and correction of hearing impairment	This component will be based on an evaluation session conducted by otolaryngologists and audiologists, who will evaluate previous hearing problems and use of hearing aids, and will include an otoscopy and an audiogram.
BEHAVIORAL	Cognitive training	This component will comprise the following activities: i. In-person group training (monthly): 60-minute sessions, supervised by a psychologist; ii. Home individual training (once a week): unsupervised 30-minutes remote sessions, using the COGWEB® online platform or paper/pencil exercises (for those participants without computer/internet or who do not use one autonomously).
BEHAVIORAL	Physical exercise	In-person group training (monthly): 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher.
BEHAVIORAL	Nutrition education	In-person group 120-minute sessions (monthly), guided by a nutritionist, comprising: presentation and discussion of healthy and easy to cook recipes by the nutritionist and preparation of healthy meals by the participants. The participants will have the opportunity to consume the prepared meals at home.
BEHAVIORAL	Capacitation to deal with cognitive decline	In-person group 60-minute sessions (monthly), guided by a psychologist, allowing participants to share experiences and learn strategies to cope with cognitive decline in their daily life.
BEHAVIORAL	Diagnosis and correction of hearing impairment	This component will be based on an evaluation session conducted by otolaryngologists and audiologists, who will evaluate previous hearing problems and use of hearing aids, and will include an otoscopy and an audiogram.

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-05-20
• Last updated: 2022-05-20

Locations

1 site across 1 country: Portugal