search
Back to results

Multiple Interventions to Prevent Cognitive Decline (MIND)

Primary Purpose

Cognitive Dysfunction, Cognition Disorders, Memory Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cognitive training
Physical activity
Nutrition education
Adaption to memory loss
Diagnosis of hearing impairment
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

a) 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;

c) Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.

Exclusion criteria:

  1. medical disability that contraindicates physical activity;
  2. lack of autonomy in daily activities.

Sites / Locations

  • Agrupamento de Centros de Saúde do Porto Ocidental

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-pharmacological intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
Body mass index
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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).
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.
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).
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).
Time of follow-up
Number of days between the first and the last session attended by the participant.
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.
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.

Full Information

First Posted
August 28, 2019
Last Updated
September 2, 2019
Sponsor
Universidade do Porto
search

1. Study Identification

Unique Protocol Identification Number
NCT04079075
Brief Title
Multiple Interventions to Prevent Cognitive Decline
Acronym
MIND
Official Title
Multiple Interventions to Prevent Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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: a) Cognitive training This 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. b) 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. c) Nutrition education This 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. d) 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. e) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Cognitive Remediation, Non-Randomized Controlled Trials as Topic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-pharmacological intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive training
Intervention Description
This 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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Intervention Description
This 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.
Intervention Type
Behavioral
Intervention Name(s)
Adaption to memory loss
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnosis of hearing impairment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive performance 1
Description
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).
Time Frame
10 months
Title
Body mass index
Description
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Time Frame
10 months
Title
Adherence to the Mediterranean diet
Description
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.
Time Frame
10 months
Title
Number of steps
Description
Variation of participant's number of steps, assessed using a portable accelerometer, between the baseline assessment and the end of follow-up.
Time Frame
10 months
Title
Adherence to each intervention
Description
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.
Time Frame
10 months
Title
Dropout
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Cognitive performance 2
Description
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.
Time Frame
10 months
Title
Memory complaints
Description
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.
Time Frame
10 months
Title
Anxiety and depression
Description
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).
Time Frame
10 months
Title
Reported quality of life: EQ-5D scale
Description
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).
Time Frame
10 months
Title
Handgrip strength
Description
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline assessment and 10 months after the beginning of the intervention.
Time Frame
10 months
Title
Agility 1
Description
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).
Time Frame
10 months
Title
Agility 2
Description
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).
Time Frame
10 months
Title
Time of follow-up
Description
Number of days between the first and the last session attended by the participant.
Time Frame
10 months
Title
Implemented sessions
Description
Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement/total number of sessions planned.
Time Frame
10 months
Title
Complete assessment of participants
Description
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.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: a) 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; c) Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points. Exclusion criteria: medical disability that contraindicates physical activity; lack of autonomy in daily activities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João Firmino-Machado, MD, PhD
Phone
+351 910961236
Email
jfdmachado@arsnorte.min-saude.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Firmino-Machado, MD, PhD
Organizational Affiliation
Instituto de Saude Publica da Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agrupamento de Centros de Saúde do Porto Ocidental
City
Porto
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Firmino-Machado, MD, PhD
Phone
+351 910961236
Email
jfdmachado@arsnorte.min-saude.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multiple Interventions to Prevent Cognitive Decline

We'll reach out to this number within 24 hrs