Multiple Interventions to Prevent Cognitive Decline

NCT04079075 | Unknown

• 1 other identifier: EPIUnit_MIND_2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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).

  10 months

• Body mass index

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

  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.

  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.

  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.

  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.

  10 months

Secondary Outcomes (10)

• 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

Study Arms (1)

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.

Other: Cognitive training; Behavioral: Physical activity; Behavioral: Nutrition education; Behavioral: Adaption to memory loss; Diagnostic Test: Diagnosis of hearing impairment

Interventions

Cognitive training OTHER

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.

Non-pharmacological intervention

Physical activity BEHAVIORAL

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.

Non-pharmacological intervention

Nutrition education BEHAVIORAL

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.

Non-pharmacological intervention

Adaption to memory loss BEHAVIORAL

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.

Non-pharmacological intervention

Diagnosis of hearing impairment DIAGNOSTIC_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.

Non-pharmacological intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• b2) clinical diagnosis of Mild Cognitive Impairment;
• c) Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score ≥ six points.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Agrupamento de Centros de Saúde do Porto Ocidental

Porto, Portugal

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Memory Disorders; Hearing Loss

Interventions

Cognitive Training; Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• João Firmino-Machado, MD, PhD

  Instituto de Saude Publica da Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Firmino-Machado, MD, PhD

CONTACT

+351 910961236; jfdmachado@arsnorte.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: September 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)