Multiple Interventions to Prevent Cognitive Decline
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universidade do Porto
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cognitive performance 1
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Non-pharmacological intervention
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: Cognitive training (Other)
Non-pharmacological intervention
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: Physical activity (Behavioral)
Non-pharmacological intervention
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: Nutrition education (Behavioral)
Non-pharmacological intervention
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: Adaption to memory loss (Behavioral)
Non-pharmacological intervention
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: Diagnosis of hearing impairment (Diagnostic Test)
Outcomes
Primary Outcomes
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).
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.
Body mass index
Time Frame: 10 months
Variation of participant's body mass index between the baseline assessment and the end of follow-up.
Secondary Outcomes
- Cognitive performance 2(10 months)
- Memory complaints(10 months)
- Anxiety and depression(10 months)
- Reported quality of life: EQ-5D scale(10 months)
- Handgrip strength(10 months)
- Agility 1(10 months)
- Agility 2(10 months)
- Time of follow-up(10 months)
- Implemented sessions(10 months)
- Complete assessment of participants(10 months)