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Clinical Trials/NCT04079075
NCT04079075
Unknown
Not Applicable

Multiple Interventions to Prevent Cognitive Decline

Universidade do Porto1 site in 1 country50 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Dysfunction
Sponsor
Universidade do Porto
Enrollment
50
Locations
1
Primary Endpoint
Cognitive performance 1
Last Updated
6 years ago

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 . 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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)

Study Sites (1)

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