MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline
- Conditions
- Cognitive DysfunctionMemory DisordersCognitive ImpairmentCognition DisorderNeurocognitive Disorders
- Interventions
- Behavioral: Cognitive trainingBehavioral: Physical exerciseBehavioral: Nutrition educationBehavioral: Capacitation to deal with cognitive declineBehavioral: Diagnosis and correction of hearing impairment
- Registration Number
- NCT05383443
- Lead Sponsor
- Instituto de Saude Publica da Universidade do Porto
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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.
- Medical disability that contraindicates physical activity;
- Lack of autonomy in daily activities;
- Previous diagnosis of dementia or severe incapacity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Capacitation to deal with cognitive decline 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. Control group Nutrition education 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. Intervention Physical exercise 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. Intervention Nutrition education 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. Intervention Diagnosis and correction of hearing impairment 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. Control group Physical exercise 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. Intervention Cognitive training 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. Control group Cognitive training 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. Control group Capacitation to deal with cognitive decline 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. Control group Diagnosis and correction of hearing impairment 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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).
Aerobic endurance Up to 12 months Variation of participant's aerobic endurance assessed using the 2-minute step test from the Senior Fitness Test.
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.
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.
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).
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.
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).
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.
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).
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 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).
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.
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.
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.
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.
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.
Time of follow-up Up to 12 months Number of days between the first and the last session attended by the participant.
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.
Trial Locations
- Locations (1)
Instituto de Saúde Pública da Universidade do Porto
🇵🇹Porto, Portugal