MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

  • STATUS
    Recruiting
  • End date
    Dec 4, 2022
  • participants needed
    300
  • sponsor
    Instituto de Saude Publica da Universidade do Porto
Updated on 4 June 2022

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.

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.

Details
Condition Cognitive Dysfunction, Cognition Disorder, Memory Disorders, Cognitive Impairment, Neurocognitive Disorders
Treatment Cognitive training, physical exercise, Nutrition Education, Capacitation to deal with cognitive decline, Diagnosis and correction of hearing impairment
Clinical Study IdentifierNCT05383443
SponsorInstituto de Saude Publica da Universidade do Porto
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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