Cognitive DysfunctionNCT05383443
MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline
A study testing Cognitive training, Physical exercise and Nutrition education in people with Cognitive Dysfunction and Cognition Disorder, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cognitive Dysfunction, Cognition Disorder, Memory Disorders
- What is being tested?
- Cognitive training, Physical exercise and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Dec 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medical disability that contraindicates physical activity;
- Lack of autonomy in daily activities;
- Previous diagnosis of dementia or severe incapacity.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Instituto de Saúde Pública da Universidade do Porto
Porto
Ana Rute Costa, PhD, 22 206 1820, arcosta@ispup.up.pt
Vítor Tedim Cruz, PhD
About this study
Official title: Multiple Interventions to Prevent Cognitive Decline (MIND-Matosinhos) - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cognitive Dysfunction, Cognition Disorder, Memory Disorders, Cognitive Impairment, Neurocognitive Disorders
- Being tested
- Cognitive training, Physical exercise, Nutrition education, Capacitation to deal with cognitive decline, Diagnosis and correction of hearing impairment
- Keywords
- Aging, Cognitive Dysfunction, Cognition Disorders, Dementia, Diet, Healthy, Exercise Therapy, Hearing Loss, Memory Disorders, Multidomain intervention, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders, Neurocognitive Disorders, Dementia, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
This component will comprise the following activities:
- 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 exerciseBehavioural
This component will be based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher:
- 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 educationBehavioural
This component will be based on the following activities:
- 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 declineBehavioural
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 impairmentOther
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 trainingBehavioural
This component will comprise the following activities:
- 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 exerciseBehavioural
In-person group training (monthly): 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher.
Nutrition educationBehavioural
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 declineBehavioural
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 impairmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive training; Behavioral: Physical exercise; Behavioral: Nutrition education; Behavioral: Capacitation to deal with cognitive decline; Behavioral: Diagnosis and correction of hearing impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 12 months
Secondary outcomes (25)
Memory complaints
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.
Measured: Up to 12 months
Cognitive performance 1
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).
Measured: Up to 12 months
Cognitive performance 2
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.
Measured: Up to 12 months
Anxiety and depression
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).
Measured: Up to 12 months
Handgrip strength
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline assessment and the end of the follow-up.
Measured: Up to 12 months
Agility 1
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).
Measured: Up to 12 months
Agility 2
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).
Measured: Up to 12 months
Upper body strength
Variation of participant's upper body strength assessed using the 30-second arm curl test from the Senior Fitness Test.
Measured: Up to 12 months
Lower body strength
Variation of participant's lower body strength assessed using the 30-second chair stand test from the Senior Fitness Test.
Measured: Up to 12 months
Upper body flexibility
Variation of participant's upper body flexibility assessed using the back-scratch test from the Senior Fitness Test.
Measured: Up to 12 months
Lower body flexibility
Variation of participant's lower body flexibility assessed using the chair sit-and-reach test from the Senior Fitness Test.
Measured: Up to 12 months
Agility 3
Variation of participant's agility and dynamic balance assessed using the 8-foot distance test (2,44 meters) from the Senior Fitness Test.
Measured: Up to 12 months
Aerobic endurance
Variation of participant's aerobic endurance assessed using the 2-minute step test from the Senior Fitness Test.
Measured: Up to 12 months
Lower limb function
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).
Measured: Up to 12 months
Levels of glycated hemoglobin
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.
Measured: Up to 12 months
24-hour urinary sodium excretion
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.
Measured: Up to 12 months
24-hour urinary potassium excretion
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.
Measured: Up to 12 months
Body mass index
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Measured: Up to 12 months
Blood pressure
Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of follow-up.
Measured: Up to 12 months
Functional capacity to perform instrumental activities of daily living
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.
Measured: Up to 12 months
Time of follow-up
Number of days between the first and the last session attended by the participant.
Measured: Up to 12 months
Implemented sessions
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.
Measured: Up to 12 months
Complete assessment of participants
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.
Measured: Up to 12 months
Adherence to each component of the intervention
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.
Measured: Up to 12 months
Dropout
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start15 Dec 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vítor Tedim Cruz, PhD, Principal investigator, Instituto de Saude Publica da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383443
- Sponsor's protocol ID
- 63/CE/JAS/2020
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Interventions to Prevent Cognitive Decline (MIND-Matosinhos) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05383443
- Acronym / sponsor ID
- 63/CE/JAS/2020
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive training, Behavioral: Physical exercise, Behavioral: Nutrition education, Behavioral: Capacitation to deal with cognitive decline, Other: Diagnosis and correction of hearing impairmentMultidomain 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 | Active comparator | Behavioral: Cognitive training, Behavioral: Physical exercise, Behavioral: Nutrition education, Behavioral: Capacitation to deal with cognitive decline, Behavioral: Diagnosis and correction of hearing impairmentMultidomain 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Medical disability that contraindicates physical activity;
- Lack of autonomy in daily activities;
- Previous diagnosis of dementia or severe incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThis 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). | Behavioural | Intervention |
| Physical exerciseThis 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. | Behavioural | Intervention |
| Nutrition educationThis 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). | Behavioural | Intervention |
| Capacitation to deal with cognitive declineThis 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. | Behavioural | Intervention |
| Diagnosis and correction of hearing impairmentThis 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. | Other | Intervention |
| Cognitive trainingThis 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). | Behavioural | Control group |
| Physical exerciseIn-person group training (monthly): 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher. | Behavioural | Control group |
| Nutrition educationIn-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. | Behavioural | Control group |
| Capacitation to deal with cognitive declineIn-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. | Behavioural | Control group |
| Diagnosis and correction of hearing impairmentThis 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. | Behavioural | Control group |
Primary outcome
Adherence to the Mediterranean diet
Time frame: 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
Time frame: 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).
25 secondary outcomes
Memory complaints
Time frame: Up to 12 months
Cognitive performance 1
Time frame: Up to 12 months
Cognitive performance 2
Time frame: Up to 12 months
Anxiety and depression
Time frame: Up to 12 months
Handgrip strength
Time frame: Up to 12 months
Agility 1
Time frame: Up to 12 months
Agility 2
Time frame: Up to 12 months
Upper body strength
Time frame: Up to 12 months
Lower body strength
Time frame: Up to 12 months
Upper body flexibility
Time frame: Up to 12 months
Lower body flexibility
Time frame: Up to 12 months
Agility 3
Time frame: Up to 12 months
Aerobic endurance
Time frame: Up to 12 months
Lower limb function
Time frame: Up to 12 months
Levels of glycated hemoglobin
Time frame: Up to 12 months
24-hour urinary sodium excretion
Time frame: Up to 12 months
24-hour urinary potassium excretion
Time frame: Up to 12 months
Body mass index
Time frame: Up to 12 months
Blood pressure
Time frame: Up to 12 months
Functional capacity to perform instrumental activities of daily living
Time frame: Up to 12 months
Time of follow-up
Time frame: Up to 12 months
Implemented sessions
Time frame: Up to 12 months
Complete assessment of participants
Time frame: Up to 12 months
Adherence to each component of the intervention
Time frame: Up to 12 months
Dropout
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vítor Tedim Cruz, PhD principal investigator
Instituto de Saude Publica da Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, Physical exercise and Nutrition education in people with Cognitive Dysfunction and Cognition Disorder, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Rute Costa, PhD (+351 22 206 1820, arcosta@ispup.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Mediterranean diet (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.