MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline
NCT ID: NCT05383443
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-12-15
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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).
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.
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).
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.
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.
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.
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).
Physical exercise
In-person group training (monthly): 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher.
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.
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.
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.
Interventions
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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).
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.
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).
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.
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.
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).
Physical exercise
In-person group training (monthly): 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Lack of autonomy in daily activities;
* Previous diagnosis of dementia or severe incapacity.
18 Years
85 Years
ALL
No
Sponsors
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Instituto de Saude Publica da Universidade do Porto
OTHER
Responsible Party
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Principal Investigators
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Vítor Tedim Cruz, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Saude Publica da Universidade do Porto
Locations
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Instituto de Saúde Pública da Universidade do Porto
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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63/CE/JAS/2020
Identifier Type: -
Identifier Source: org_study_id
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