MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

NCT05383443 | Unknown

• 1 other identifier: 63/CE/JAS/2020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Cognition Disorder; Memory Disorders; Cognitive Impairment; Neurocognitive Disorders

Keywords

Aging; Cognitive Dysfunction; Cognition Disorders; Dementia; Diet, Healthy; Exercise Therapy; Hearing Loss; Memory Disorders; Multidomain intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Adherence to the Mediterranean diet

  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.

  Up to 12 months

• Self-reported quality of life

  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).

  Up to 12 months

Secondary Outcomes (25)

• Memory complaints

  Up to 12 months

• Cognitive performance 1

  Up to 12 months

• Cognitive performance 2

  Up to 12 months

• Anxiety and depression

  Up to 12 months

• Handgrip strength

  Up to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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; Behavioral: Physical exercise; Behavioral: Nutrition education; Behavioral: Capacitation to deal with cognitive decline; Other: Diagnosis and correction of hearing impairment

Control group

ACTIVE COMPARATOR

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; Behavioral: Physical exercise; Behavioral: Nutrition education; Behavioral: Capacitation to deal with cognitive decline; Behavioral: Diagnosis and correction of hearing impairment

Interventions

Cognitive training BEHAVIORAL

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).

Intervention

Physical exercise BEHAVIORAL

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.

Intervention

Nutrition education BEHAVIORAL

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).

Intervention

Capacitation to deal with cognitive decline BEHAVIORAL

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.

Intervention

Diagnosis and correction of hearing impairment OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medical disability that contraindicates physical activity;
• Lack of autonomy in daily activities;
• Previous diagnosis of dementia or severe incapacity.

Sponsors & Collaborators

• Instituto de Saude Publica da Universidade do Porto: lead

Study Sites (1)

Instituto de Saúde Pública da Universidade do Porto

Porto, Portugal

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Memory Disorders; Neurocognitive Disorders; Dementia; Hearing Loss

Interventions

Cognitive Training; Exercise; Nutrition Assessment; Correction of Hearing Impairment

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Vítor Tedim Cruz, PhD

  Instituto de Saude Publica da Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Rute Costa, PhD

CONTACT

+351 22 206 1820; arcosta@ispup.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 20, 2022
• Study Start: December 15, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)