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Multiple Interventions to Prevent Cognitive Decline (MIND)

U

Universidade do Porto

Status

Unknown

Conditions

Cognition Disorders
Memory Disorders
Cognitive Dysfunction

Treatments

Behavioral: Nutrition education
Behavioral: Physical activity
Diagnostic Test: Diagnosis of hearing impairment
Behavioral: Adaption to memory loss
Other: Cognitive training

Study type

Interventional

Funder types

Other

Identifiers

NCT04079075
EPIUnit_MIND_2019

Details and patient eligibility

About

The investigators aim to test the feasibility of a pragmatic non-pharmacological strategy, that may prevent cognitive decline in patients with mild cognitive impairment. This strategy is based on five different interventions: cognitive training, physical activity, nutrition education, adaption to memory loss, diagnosis and correction of hearing impairment.

A quasi-experimental study will be implemented in Porto (Portugal), including patients that fulfill all of the following criteria: a) age 18-85 years; b) Montreal Cognitive Assessment (MoCA) score greater than or equal to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population OR diagnosis of Mild Cognitive Impairment, performed by a Neurologist, during the six previous months, considering the results of a neuropsychological battery; c) Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score of at least six points. Patients who have any medical disability that contraindicates physical activity or have a lack of autonomy in daily activities will be excluded.

The program will be implemented in groups of 10 participants, over a period of 10 consecutive months.

Full description

Detailed description

This is a quasi-experimental study in which the investigators aim to test the feasibility of a non-pharmacological strategy to prevent cognitive decline in patients with a diagnosis of mild cognitive impairment. This strategy is based on five different interventions:

a) Cognitive training

This comprises training using using the cogweb software, both in person and remotely:

i) in person training: 30-minute sessions, supervised by a trained nurse, twice weekly .

ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will.

b) Physical activity This is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly.

c) Nutrition education

This is based on monthly 180-minute sessions, directed by a nutritionist, comprising:

i) Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared.

d) Adaptation to memory loss This is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss.

e) Diagnosis of hearing impairment Before implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist.

Strategies (a),(b), (c) and (d) will be implemented over a period of 10 months, in groups of 10 participants.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

a) Age 18-85 years;

b1) Montreal Cognitive Assessment score ≥ to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population;

OR

b2) clinical diagnosis of Mild Cognitive Impairment;

c) Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.

Exclusion criteria

  1. medical disability that contraindicates physical activity;
  2. lack of autonomy in daily activities.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Non-pharmacological intervention
Experimental group
Description:
Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions: cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment.
Treatment:
Other: Cognitive training
Behavioral: Nutrition education
Diagnostic Test: Diagnosis of hearing impairment
Behavioral: Adaption to memory loss
Behavioral: Physical activity

Trial contacts and locations

1

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Central trial contact

João Firmino-Machado, MD, PhD

Data sourced from clinicaltrials.gov

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