Cognitive DysfunctionMINDNCT04079075
Multiple Interventions to Prevent Cognitive Decline
A study testing Cognitive training, Physical activity and Nutrition education in people with Cognitive Dysfunction and Cognition Disorders, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The investigators aim to test the feasibility of a pragmatic non-pharmacological strategy, that may prevent cognitive decline in patients with mild cognitive impairment. This strategy is based on five different interventions: cognitive training, physical activity, nutrition education, adaption to memory loss… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders
- What is being tested?
- Cognitive training, Physical activity and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2019to Dec 2020
- 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;
- b1) Montreal Cognitive Assessment score ≥ to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population;
- OR
- b2) clinical diagnosis of Mild Cognitive Impairment;
- Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.
Who cannot join
- medical disability that contraindicates physical activity;
- lack of autonomy in daily activities.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Agrupamento de Centros de Saúde do Porto Ocidental
Porto
João Firmino-Machado, MD, PhD, +351 910961236, jfdmachado@arsnorte.min-saude.pt
About this study
The investigators aim to test the feasibility of a pragmatic non-pharmacological strategy, that may prevent cognitive decline in patients with mild cognitive impairment. This strategy is based on five different interventions: cognitive training, physical activity, nutrition education, adaption to memory loss, diagnosis and correction of hearing impairment.
A quasi-experimental study will be implemented in Porto (Portugal), including patients that fulfill all of the following criteria: a) age 18-85 years; b) Montreal Cognitive Assessment (MoCA) score greater than or equal to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population OR diagnosis of Mild Cognitive Impairment, performed by a Neurologist, during the six previous months, considering the results of a neuropsychological battery; c) Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score of at least six points. Patients who have any medical disability that contraindicates physical activity or have a lack of autonomy in daily activities will be excluded.
The program will be implemented in groups of 10 participants, over a period of 10 consecutive months.
Read the detailed description
Detailed description
This is a quasi-experimental study in which the investigators aim to test the feasibility of a non-pharmacological strategy to prevent cognitive decline in patients with a diagnosis of mild cognitive impairment. This strategy is based on five different interventions:
- Cognitive training
This comprises training using using the cogweb software, both in person and remotely:
- in person training: 30-minute sessions, supervised by a trained nurse, twice weekly . ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will.
- Physical activity This is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly.
- Nutrition education
This is based on monthly 180-minute sessions, directed by a nutritionist, comprising:
- Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared.
- Adaptation to memory loss This is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss.
- Diagnosis of hearing impairment Before implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist.
Strategies (a),(b), (c) and (d) will be implemented over a period of 10 months, in groups of 10 participants.
- Conditions
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders
- Being tested
- Cognitive training, Physical activity, Nutrition education, Adaption to memory loss, Diagnosis of hearing impairment
- Keywords
- Correction of Hearing Impairment, Cognitive Dysfunction, Diet, Healthy, Exercise Therapy, Cognition Disorders, Neuropsychological Tests, Hearing Loss, Memory Disorders, Cognitive Remediation, Non-Randomized Controlled Trials as Topic
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
This comprises training using using the cogweb software, both in person and remotely:
- in person training: 30-minute sessions, supervised by a trained nurse, twice weekly . ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will.
Physical activityBehavioural
This is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly.
Nutrition educationBehavioural
This is based on monthly 180-minute sessions, directed by a nutritionist, comprising:
- Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared.
Adaption to memory lossBehavioural
This is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss.
Diagnosis of hearing impairmentDiagnostic test
Before implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist.
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological intervention | Experimental | Non-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions:
cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment. Receives: Other: Cognitive training; Behavioral: Physical activity; Behavioral: Nutrition education; Behavioral: Adaption to memory loss; Diagnostic Test: Diagnosis of hearing impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance 1
Variation of participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of follow-up. This scale varies from 0 (worst cognitive performance) to 30 points (best cognitive performance).
Measured: 10 months
Body mass index
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Measured: 10 months
Adherence to the Mediterranean diet
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern (PREDIMED) scale, 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: 10 months
Number of steps
Variation of participant's number of steps, assessed using a portable accelerometer, between the baseline assessment and the end of follow-up.
Measured: 10 months
Adherence to each intervention
Proportion of adherence to each intervention and component of each intervention, calculated as the number of sessions attended/total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.
Measured: 10 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/total number of participants who attended at least one session.
Measured: 10 months
Secondary outcomes (10)
Cognitive performance 2
Variation of participant's cognitive performance assessed using a neuropsychological battery, between the baseline assessment and the end of 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: 10 months
Memory complaints
Variation of the self-reported memory complaints, assessed using the self-reported 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: 10 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 follow-up. This scale varies from 0 (best score) to 21 points (worst score).
Measured: 10 months
Reported quality of life: EQ-5D scale
Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline assessment and 10 months after the beginning of the intervention. This is assessed using 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: 10 months
Handgrip strength
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline assessment and 10 months after the beginning of the intervention.
Measured: 10 months
Agility 1
Variation of participant's agility and balance, assessed using the Time Up and Go Test scale, between the baseline assessment and 10 months after the beginning of the intervention. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Measured: 10 months
Agility 2
Variation of participant's agility and balance, assessed using the One Leg Balance Test, between the baseline assessment and 10 months after the beginning of the intervention. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Measured: 10 months
Time of follow-up
Number of days between the first and the last session attended by the participant.
Measured: 10 months
Implemented sessions
Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement/total number of sessions planned.
Measured: 10 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/total number of participants evaluated.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Sep 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Firmino-Machado, MD, PhD, Principal investigator, Instituto de Saude Publica da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079075
- Sponsor's protocol ID
- EPIUnit_MIND_2019
- Acronym
- MIND
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 6 Sep 2019
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Interventions to Prevent Cognitive Decline
- ClinicalTrials.gov ID
- NCT04079075
- Acronym / sponsor ID
- MIND / EPIUnit_MIND_2019
- Conditions
- Cognitive Dysfunction, Cognition Disorders, Memory Disorders
- Keywords
- Correction of Hearing Impairment, Cognitive Dysfunction, Diet, Healthy, Exercise Therapy, Cognition Disorders, Neuropsychological Tests, Hearing Loss, Memory Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Sep 2019 (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 investigators aim to test the feasibility of a pragmatic non-pharmacological strategy, that may prevent cognitive decline in patients with mild cognitive impairment. This strategy is based on five different interventions: cognitive training, physical activity, nutrition education, adaption to memory loss, diagnosis and correction of hearing impairment.
A quasi-experimental study will be implemented in Porto (Portugal), including patients that fulfill all of the following criteria: a) age 18-85 years; b) Montreal Cognitive Assessment (MoCA) score greater than or equal to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population OR diagnosis of Mild Cognitive Impairment, performed by a Neurologist, during the six previous months, considering the results of a neuropsychological battery; c) Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score of at least six points. Patients who have any medical disability that contraindicates physical activity or have a lack of autonomy in daily activities will be excluded.
The program will be implemented in groups of 10 participants, over a period of 10 consecutive months.
Detailed description
Detailed description
This is a quasi-experimental study in which the investigators aim to test the feasibility of a non-pharmacological strategy to prevent cognitive decline in patients with a diagnosis of mild cognitive impairment. This strategy is based on five different interventions:
- Cognitive training
This comprises training using using the cogweb software, both in person and remotely:
- in person training: 30-minute sessions, supervised by a trained nurse, twice weekly . ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will.
- Physical activity This is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly.
- Nutrition education
This is based on monthly 180-minute sessions, directed by a nutritionist, comprising:
- Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared.
- Adaptation to memory loss This is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss.
- Diagnosis of hearing impairment Before implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist.
Strategies (a),(b), (c) and (d) will be implemented over a period of 10 months, in groups of 10 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological intervention | Experimental | Other: Cognitive training, Behavioral: Physical activity, Behavioral: Nutrition education, Behavioral: Adaption to memory loss, Diagnostic Test: Diagnosis of hearing impairmentNon-pharmacological strategy, implemented in groups of 10 participants, over 10 consecutive months, based on five different interventions: cognitive training, physical activity; nutrition education; adaption to memory loss; detection and correction of hearing impairment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-85 years;
- b1) Montreal Cognitive Assessment score ≥ to two standard deviations below the normative reference value for the corresponding age and education level in the Portuguese population;
- OR
- b2) clinical diagnosis of Mild Cognitive Impairment;
- Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.
Key exclusion criteria (2 listed)
- medical disability that contraindicates physical activity;
- lack of autonomy in daily activities.
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 comprises training using using the cogweb software, both in person and remotely: i) in person training: 30-minute sessions, supervised by a trained nurse, twice weekly . ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will. | Other | Non-pharmacological intervention |
| Physical activityThis is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly. | Behavioural | Non-pharmacological intervention |
| Nutrition educationThis is based on monthly 180-minute sessions, directed by a nutritionist, comprising: i) Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared. | Behavioural | Non-pharmacological intervention |
| Adaption to memory lossThis is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss. | Behavioural | Non-pharmacological intervention |
| Diagnosis of hearing impairmentBefore implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist. | Diagnostic test | Non-pharmacological intervention |
Primary outcome
Cognitive performance 1
Time frame: 10 months
Variation of participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of follow-up. This scale varies from 0 (worst cognitive performance) to 30 points (best cognitive performance).
Body mass index
Time frame: 10 months
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Adherence to the Mediterranean diet
Time frame: 10 months
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern (PREDIMED) scale, 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.
Number of steps
Time frame: 10 months
Variation of participant's number of steps, assessed using a portable accelerometer, between the baseline assessment and the end of follow-up.
Adherence to each intervention
Time frame: 10 months
Proportion of adherence to each intervention and component of each intervention, calculated as the number of sessions attended/total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.
Dropout
Time frame: 10 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/total number of participants who attended at least one session.
10 secondary outcomes
Cognitive performance 2
Time frame: 10 months
Memory complaints
Time frame: 10 months
Anxiety and depression
Time frame: 10 months
Reported quality of life: EQ-5D scale
Time frame: 10 months
Handgrip strength
Time frame: 10 months
Agility 1
Time frame: 10 months
Agility 2
Time frame: 10 months
Time of follow-up
Time frame: 10 months
Implemented sessions
Time frame: 10 months
Complete assessment of participants
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
João Firmino-Machado, MD, 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 activity and Nutrition education in people with Cognitive Dysfunction and Cognition Disorders, run by 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 5 inclusion and 2 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 6 Sep 2019. 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 João Firmino-Machado, MD, PhD (+351 910961236, jfdmachado@arsnorte.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance 1 (time frame: 10 months). The study lists 6 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 6 Sep 2019.