Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad

Summary

With the aging of the population, an increase in neurocognitive diseases such as dementia is projected. Mild cognitive impairment is considered a precursor stage to dementia, with opportunities for intervention to prevent its progression. Additionally, these illnesses can harm the primary caregiver, who is often an unskilled family member. This is a randomized clinical trial in patients with mild cognitive impairment and their main caregivers.

The intervention will be tested in the dyad for 12 weeks, twice a week with professional support and once a week with caregiver support, the latter will be intervened once a week for 12 weeks. The primary outcome will be the change in cognitive function and its domains. Secondary outcomes will evaluate favorable changes in quality of life in the patient-caregiver couple, frailty, physical capacity, independence, nutritional status, social support, and family caregiver burden. These measurements will be taken at baseline, 3, 6, and 9 months of follow-up. Furthermore, in a subsample of the study population, the taxonomic and metabolomic composition of the intestinal microbiota and the presence of the E4 allele of the APOE (apolipoprotein E) gene will be evaluated before and after the intervention.

Conditions

• Mild Cognitive Impairment

Interventions

OTHER

Multi-component, transdisciplinary and multifocal intervention for the cognition

Multi-component intervention (12 weeks, twice/week, with professional support at home) Physical activity for the patient: dual training, strength, balance, with intensity increase monthly, plus moderate walking of 30 minutes/day, 5 days per week. Nutritional advice for the patient: Month 1- reduction of added sugars and processed carbohydrates. Month 2- increase consumption of healthy fats and reduction of saturated fats; Month 3- increase in consumption of fruits and vegetables, and a monthly group practical workshop. Cognitive training for the patient: activities focused on orientation, attention and concentration, working memory, mathematical reasoning, language, visual construction, executive functions, and reminiscence therapy. Accompaniment for the family member: Activities aimed at care and self-care, understanding cognitive deterioration and its progression, support for patient adherence to the intervention, and activities in groups once a week.

Sponsors & Collaborators

• Universidad Manuela Beltrán

  collaborator OTHER

• Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

  collaborator OTHER

• Universidad Autónoma de Bucaramanga

  collaborator OTHER

• Universidad Santo Tomas

  collaborator OTHER

• Ministerio de Ciencia Tecnología e Innovación - Minciencias

  collaborator UNKNOWN

• Universidad de Santander

  lead OTHER

Principal Investigators

• Diana Tiga Loza · Universidad de Santander

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-30

Primary Completion

2026-07-28

Completion

2026-10-31

Countries

• Colombia

Study Locations