Multiple Interventions to Prevent Cognitive Decline

NCT ID: NCT04079075

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed 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.

Conditions

Cognitive Dysfunction; Cognition Disorders; Memory Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Non-pharmacological intervention

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.

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: OTHER

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.

Physical activity

Intervention Type: BEHAVIORAL

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.

Nutrition education

Intervention Type: BEHAVIORAL

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.

Adaption to memory loss

Intervention Type: BEHAVIORAL

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.

Diagnosis of hearing impairment

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Adaption 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

João Firmino-Machado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Saude Publica da Universidade do Porto

Locations

Agrupamento de Centros de Saúde do Porto Ocidental

Porto, , Portugal

Countries

Portugal

Central Contacts

João Firmino-Machado, MD, PhD

Role: CONTACT

jfdmachado@arsnorte.min-saude.pt

+351 910961236

Facility Contacts

João Firmino-Machado, MD, PhD

Role: primary

jfdmachado@arsnorte.min-saude.pt

+351 910961236

Other Identifiers

EPIUnit_MIND_2019

Identifier Type: -

Identifier Source: org_study_id