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RECRUITING

NCT06408103

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

Sponsor: Universidad de Santander

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2024-07-30

Completion Date

2025-11

Last Updated

2024-12-06

Healthy Volunteers

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.

Inclusion and exclusion criteria for elderly adults Inclusion criteria 1. Age of 55 years or older. 2. Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation. 3. Functionality for instrumental activities. 4. Basic proficiency in reading and writing. 5. Absence of untreated hearing impairment and/or uncorrected visual problems. 6. Availability of a primary family caregiver (to be identified). 7. IPAQ with low level of physical activity (pending cutoff point), PARQ and you Fit (pending review). 8. Barthel Index equal to or greater than 80 points. 9. Functional capacity for short-distance ambulation without permanent use of mechanical aids such as wheelchairs. 10. Individuals with a BMI greater than 18.5. 11. Gastrointestinal tract without surgical resections. 12. Tolerance to oral feeding. 13. Vaccination against COVID-19. Exclusion criteria 1. History of psychosis or congenital intellectual disability. 2. Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury). 3. Presence of untreated psychiatric disorders, anxiety, depression (Yesavage). 4. Presence of clinically significant systemic diseases (thyroid dysfunction, vitamin B12 deficiency, insulin-dependent diabetes, syphilis, HIV infection, Epstein Barr infection, advanced stage renal failure, cirrhosis). Evaluated through medical history and self-report. 5. Older adult with Chronic Kidney Disease, Hepatopathies (hepatitis, liver cirrhosis), 6. Pulmonary Diseases, or requiring oxygen support, Crohn's Disease, and Colitis. 7. Individual with oncological pathology who has received or is receiving chemotherapy. 8. Individual who has received probiotics or prebiotics in the last 30 days. 9. Presence of clinically significant, active infectious etiology diarrhea. 10. Current or prior abuse of alcohol, tobacco, or drugs. 11. Use of steroids or immunosuppressants in the last 30 days. 12. Recent use of antibiotics, antifungals, or antivirals (excluding topicals) in the last 3 months. 13. Individual who voluntarily decides to withdraw from the study. 14. Older adult without oral, enteral, or parenteral nutritional support. 15. Poor tolerance to exercise, vertigo, medical exercise restriction. Elimination criteria 1. Institutionalized or hospitalized for more than 1 week, or death during the intervention phase (review and clarity on death). 2. Failure to attend more than 34% of sessions with professional accompaniment (applies to the dyad). Inclusion and exclusion criteria for caregivers ( Family members) Inclusion criteria 1. Adults aged 18 years or older. 2. Basic proficiency in reading and writing. 3. Having a level of kinship (consanguineous or non-consanguineous). 4. Vaccination against COVID-19.

Locations (1)

Universidad de Santander / Universidad Manuela Beltrán /FOSCAL

Bucaramanga, Santander Department, Colombia