MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

Sponsor

Instituto de Saude Publica da Universidade do Porto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05383443

Collaborator

(none)

300

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Dysfunction Cognition Disorder Memory Disorders Cognitive Impairment Neurocognitive Disorders	Behavioral: Cognitive training Behavioral: Physical exercise Behavioral: Nutrition education Behavioral: Capacitation to deal with cognitive decline Other: Diagnosis and correction of hearing impairment Behavioral: Cognitive training Behavioral: Physical exercise Behavioral: Nutrition education Behavioral: Capacitation to deal with cognitive decline Behavioral: Diagnosis and correction of hearing impairment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 15, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. The intervention plan includes home training activities of identical intensity for participants with and without access or autonomy to use computer/internet. It will comprise individual and group sessions over three months, possibly extensible up to 12 months. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.	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.
Active Comparator: Control group Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. It will comprise individual and group sessions, over three months (possibly extensible up to 12 months), conducted with a lower frequency in comparison with the intervention group. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.	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.

Arm

Intervention/Treatment

Experimental: Intervention

Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. The intervention plan includes home training activities of identical intensity for participants with and without access or autonomy to use computer/internet. It will comprise individual and group sessions over three months, possibly extensible up to 12 months. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.

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.

Active Comparator: Control group

Multidomain non-pharmacological intervention, including cognitive training, physical exercise, nutrition education, capacitation to deal with cognitive decline, and diagnosis and correction of hearing impairment. It will comprise individual and group sessions, over three months (possibly extensible up to 12 months), conducted with a lower frequency in comparison with the intervention group. Caregivers or partners of all participants will be invited to participate in the activities of nutrition education and capacitation to deal with cognitive decline.

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

Outcome Measures

Primary Outcome Measures

Adherence to the Mediterranean diet [Up to 12 months]
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern scale (MEDAS), between the baseline assessment and the end of follow-up. This scale varies from 0 (lowest adherence to the Mediterranean diet) to 14 points (highest adherence to the Mediterranean diet). A score over 10 points indicates good adherence to the Mediterranean diet.
Self-reported quality of life [Up to 12 months]
Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline assessment and the end of follow-up. This scale is subdivided in two subscales: a) five multiple choice questions, with five response possibilities, which produce a score that varies from 5 (best score) to 25 points (worst score); b) visual analogic scale, that varies from 0 (worst score) to 100 (best score).

Secondary Outcome Measures

Memory complaints [Up to 12 months]
Variation of the self-reported memory complaints, assessed using the Subjective Memory Complaints Scale, between the baseline assessment and the end of follow-up. This scale varies from 0 (best score) to 21 points (worst score). Scores over three points indicate the presence of self-reported memory complaints.
Cognitive performance 1 [Up to 12 months]
Variation of participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of the follow-up. This scale varies from 0 (worst cognitive performance) to 30 points (best cognitive performance).
Cognitive performance 2 [Up to 12 months]
Variation of participant's cognitive performance assessed using a neuropsychological battery tests, between the baseline assessment and the end of the follow-up. This will be reported in the format of a Z-score, assuming positive and negative values. Higher scores indicate better cognitive performance.
Anxiety and depression [Up to 12 months]
Variation of the anxiety and depression scores, assessed using the Hospital Anxiety and Depression Scale (HADS), between the baseline assessment and the end of the follow-up. This scale varies from 0 (best score) to 21 points (worst score).
Handgrip strength [Up to 12 months]
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline assessment and the end of the follow-up.
Agility 1 [Up to 12 months]
Variation of participant's agility and balance, assessed using the Timed Up and Go Test scale, between the baseline assessment and the end of the follow-up. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Agility 2 [Up to 12 months]
Variation of participant's agility and balance, assessed using the Unipedal Stance Test, between the baseline assessment and the end of the follow-up. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Upper body strength [Up to 12 months]
Variation of participant's upper body strength assessed using the 30-second arm curl test from the Senior Fitness Test.
Lower body strength [Up to 12 months]
Variation of participant's lower body strength assessed using the 30-second chair stand test from the Senior Fitness Test.
Upper body flexibility [Up to 12 months]
Variation of participant's upper body flexibility assessed using the back-scratch test from the Senior Fitness Test.
Lower body flexibility [Up to 12 months]
Variation of participant's lower body flexibility assessed using the chair sit-and-reach test from the Senior Fitness Test.
Agility 3 [Up to 12 months]
Variation of participant's agility and dynamic balance assessed using the 8-foot distance test (2,44 meters) from the Senior Fitness Test.
Aerobic endurance [Up to 12 months]
Variation of participant's aerobic endurance assessed using the 2-minute step test from the Senior Fitness Test.
Lower limb function [Up to 12 months]
Variation of participant's lower limb function, assessed using the Short Physical Performance Battery (SPPB), which tests 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4; total score ranges from 0 (poor performance) to 12 (best performance).
Levels of glycated hemoglobin [Up to 12 months]
Variation of participant's levels of glycated hemoglobin, between the baseline assessment and the end of follow-up. This parameter will be measured through a laboratory analysis of participants' blood sample and will be used to analyze glycemic control.
24-hour urinary sodium excretion [Up to 12 months]
Variation of participant's urinary sodium excretion, between the baseline and the follow-up assessments. This parameter will be measured through a laboratory analysis of participants' 24-hour urinary samples and will be analyzed as a proxy of dietary salt intake.
24-hour urinary potassium excretion [Up to 12 months]
Variation of participant's urinary potassium excretion, between the baseline and the follow-up assessments. This parameter will be measured through a laboratory analysis of participants' 24-hour urinary samples and will be analyzed as a proxy of dietary potassium intake.
Body mass index [Up to 12 months]
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Blood pressure [Up to 12 months]
Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of follow-up.
Functional capacity to perform instrumental activities of daily living [Up to 12 months]
Variation of participant's independence on performing instrumental activities of daily living, using the Lawton & Brody scale, which ranges from 0 to 8 and higher scores represent increased functional capacity to perform instrumental activities.
Time of follow-up [Up to 12 months]
Number of days between the first and the last session attended by the participant.
Implemented sessions [Up to 12 months]
Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement divided by the total number of sessions planned.
Complete assessment of participants [Up to 12 months]
For each study outcome, proportion of participants with complete information, calculated at baseline and different moments of follow-up, as the number of participants with complete information divided by the total number of participants evaluated.
Adherence to each component of the intervention [Up to 12 months]
Proportion of adherence to each component of the intervention and to different intervention modalities (remote/in person), calculated as the number of sessions attended divided by the total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.
Dropout [Up to 12 months]
Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session divided by the total number of participants who attended at least one session.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.