Clinical trial NCT05383443: MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline
Official title: Multiple Interventions to Prevent Cognitive Decline (MIND-Matosinhos) - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Cognition Disorder
Memory Disorders
Cognitive Impairment
Neurocognitive Disorders
Keywords: Aging
Cognitive Dysfunction
Cognition Disorders
Dementia
Diet, Healthy
Exercise Therapy
Hearing Loss
Memory Disorders
Multidomain intervention
Randomized Controlled Trial
Lead sponsor: Instituto de Saude Publica da Universidade do Porto
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-85 years;
* Score equal or higher than the validated cutoff points defined as 2 standard deviations below the mean for age and education in the Montreal Cognitive Assessment (MoCA);
* ≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE);
* ≥4 years of schooling.

Exclusion Criteria:

* Medical disability that contraindicates physical activity;
* Lack of autonomy in daily activities;
* Previous diagnosis of dementia or severe incapacity.

Primary outcomes:
measure: Adherence to the Mediterranean diet
timeFrame: Up to 12 months
measure: Self-reported quality of life
timeFrame: Up to 12 months
Secondary outcomes:
measure: Memory complaints
timeFrame: Up to 12 months
measure: Cognitive performance 1
timeFrame: Up to 12 months
measure: Cognitive performance 2
timeFrame: Up to 12 months
measure: Anxiety and depression
timeFrame: Up to 12 months
measure: Handgrip strength
timeFrame: Up to 12 months
measure: Agility 1
timeFrame: Up to 12 months
measure: Agility 2
timeFrame: Up to 12 months
measure: Upper body strength
timeFrame: Up to 12 months
measure: Lower body strength
timeFrame: Up to 12 months
measure: Upper body flexibility
timeFrame: Up to 12 months
measure: Lower body flexibility
timeFrame: Up to 12 months
measure: Agility 3
timeFrame: Up to 12 months
measure: Aerobic endurance
timeFrame: Up to 12 months
measure: Lower limb function
timeFrame: Up to 12 months
measure: Levels of glycated hemoglobin
timeFrame: Up to 12 months
measure: 24-hour urinary sodium excretion
timeFrame: Up to 12 months
measure: 24-hour urinary potassium excretion
timeFrame: Up to 12 months
measure: Body mass index
timeFrame: Up to 12 months
measure: Blood pressure
timeFrame: Up to 12 months
measure: Functional capacity to perform instrumental activities of daily living
timeFrame: Up to 12 months
measure: Time of follow-up
timeFrame: Up to 12 months
measure: Implemented sessions
timeFrame: Up to 12 months
measure: Complete assessment of participants
timeFrame: Up to 12 months
measure: Adherence to each component of the intervention
timeFrame: Up to 12 months
measure: Dropout
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto de Saúde Pública da Universidade do Porto
Study officials:
affiliation: Instituto de Saude Publica da Universidade do Porto
name: Vítor Tedim Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References: