Clinical trial NCT04079075: Multiple Interventions to Prevent Cognitive Decline
Official title: Multiple Interventions to Prevent Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Cognitive Remediation
Non-Randomized Controlled Trials as Topic
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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:

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

Primary outcomes:
measure: Cognitive performance 1
timeFrame: 10 months
measure: Body mass index
timeFrame: 10 months
measure: Adherence to the Mediterranean diet
timeFrame: 10 months
measure: Number of steps
timeFrame: 10 months
measure: Adherence to each intervention
timeFrame: 10 months
measure: Dropout
timeFrame: 10 months
Secondary outcomes:
measure: Cognitive performance 2
timeFrame: 10 months
measure: Memory complaints
timeFrame: 10 months
measure: Anxiety and depression
timeFrame: 10 months
measure: Reported quality of life: EQ-5D scale
timeFrame: 10 months
measure: Handgrip strength
timeFrame: 10 months
measure: Agility 1
timeFrame: 10 months
measure: Agility 2
timeFrame: 10 months
measure: Time of follow-up
timeFrame: 10 months
measure: Implemented sessions
timeFrame: 10 months
measure: Complete assessment of participants
timeFrame: 10 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Agrupamento de Centros de Saúde do Porto Ocidental
Study officials:
affiliation: Instituto de Saude Publica da Universidade do Porto
name: João Firmino-Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: