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Cognitive Stimulation in Older With Mild Cognitive Impairment

U

University of Zaragoza

Status

Completed

Conditions

Mild Cognitive Impairment
Randomized Controlled Trial

Treatments

Other: Cognitive stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03831061
School of Health Sciences

Details and patient eligibility

About

The participants who carry out our program of cognitive stimulation, deteriorate at a cognitive level more slowly and can improve their score of the Spanish version of 35 points of Mini-mental State of Folstein; Mini-exam Cognoscitive of Lobo.

Full description

The aim of our research is to evaluate the effect of a cognitive stimulation program in people aged 65 or older with mild cognitive impairment (MCI) and compare it, in the short, medium and long term, with the evolution of other people, with the same characteristics and for which this intervention has not been carried out.

The significant increase in the number of people over 65 years of age in relation to the total population, suggests a significant increase in age-related pathologies. The problem that entails population aging increases when cognitive deterioration appears.

From an economic perspective, the cognitive deterioration of the elderly person is estimated to contribute to health expenses of almost ten times more compared to people of the same age with cognitive functions preserved. Different studies show that a considerable proportion of people with MCI have a high risk of developing dementia and Alzheimer's disease.

Cognitive stimulation is a treatment that has shown profitability and has been recommended as the treatment of choice in MCI.

Our research is based on a cognitive stimulation that uses the Red Book of Mental Activation. The book consists of 4 practical exercises that work 10 cognitive aspects (memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, attention and programming); in total 40 exercises. The models on which the notebook is based is the cognitive model and the human occupation model.

In the Health Center San José Norte-Centro of Zaragoza (Spain), assessments were made to 416 volunteer candidates, of which 294 were excluded for not meeting the inclusion criteria; being a total of 122 participants that have been part of the randomized controlled trial. Of the 122 participants; 54 have carried out the intervention as an intervention group and 68 as the control group. The control group did not perform any type of intervention.

The intervention was carried out at the La Caridad de Zaragoza Foundation (Spain), consisting of 10 sessions of 45 minutes/week during 10 weeks. The conceptual framework of this intervention is formed by the International Classification of Functioning and Disability (CIF), the framework for practice of Occupational Therapy , the cognitive model and the human occupation model of Gary Kielhofner .

To homogenize both the assessments and the intervention, a standardized training was carried out for the occupational therapists who carried them out and consisted of a theoretical part and a practical part of 10 hours each.

The study began in December 2011, obtained the authorization of the Directorate of Primary Care of the Zaragoza II Sector and the approval of the project by the Research Ethics Committee of the Government of Aragon (CEICA). This study has followed the ethical standards recognized by the Declaration of Helsinki. The initial assessments began this month. The necessary sample size was reached in October 2012 and, from that moment on, randomization and intervention with the selected participants was carried out. Three other assessments were made, both for the intervention group and for the control group, immediately after the intervention, six months and one year after the intervention.

Enrollment

122 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Older adults (age ≥ 65)
  • Community (not institutionalized)
  • Mini-Examen Cognoscitive (MEC) score 24-27 points
  • Barthel index > 60 points
  • No received cognitive stimulation in the last year
  • Hearing problems that interfere with the intervention
  • Blindness or vision problems that interfere with the intervention
  • Neuropsychiatric disorders (agitation, delusions or hallucinations)
  • Motor difficulties that interfere with the intervention.

Exclusion criteria

  • No agree to participate and no sign the informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 2 patient groups

Cognitive stimulation
Experimental group
Description:
10 sessions of 45 minutes/week during 10 weeks. Each session included : (a) temporo-spatial orientation , (b) activities related to memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, visual attention, and executive functions, (c) individual practical exercises and (d) correction of the practical exercises. There are 54 participants subdivided into two groups of 27 participants that perform the same intervention in different days of the week.
Treatment:
Other: Cognitive stimulation
Control group (No intervention)
No Intervention group
Description:
There are 68 participants in total. These participants did not receive intervention.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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