Clinical trial NCT04648670: Cognitive Stimulation Program in Elderly
Official title: Cognitive Stimulation Program in Elderly With Normal Cognition: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Controlled Trial
Occupational Therapy
Aging
Cognitive Change
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 201
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intervention group and a control group with the same characteristics are included.
Primary purpose: TREATMENT

Brief summary: The participants who carry out our cognitive stimulation program maintain and / or improve their score of the 35-point Spanish version of 35 points of Mini-mental State of Folstein; Mini-exam Cognoscitive of Lobo

Detailed description: The aim of our research is to evaluate the effect of a cognitive stimulation program in older adults aged 65 or over The intervention was carried out at the Foundation of Zaragoza (Spain), consisting of 10 sessions of 45 minutes/week during 10 weeks.with normal cognition 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. Prevention is essential to avoid cognitive aging and preserve higher mental functions.

From an economic perspective, it is estimated that people with mild cognitive impairment produce 16% more spending than those with normal cognition.

Cognitive stimulation is a low-cost non-pharmacological treatment that has shown its benefits in the preservation of cognitive aspects based on the brain plasticity it generates.

Our research is based on cognitive stimulation using the yellow and Orange Mental Activation notebooks, levels that correspond to the scores of Lobo's cognitive Mini-test. The book consists of 4 practical exercises that work on 10 cognitive aspects (memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, attention and programming); in total 40 exercises. The models on which the laptop is based are 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 215 were excluded for not meeting the inclusion criteria; being a total of 201participants that have been part of the randomized controlled trial. Of the 201 participants; 101 have carried out the intervention as an intervention group and 100 as the control group. The control group did not perform any type of intervention.

The intervention was carried out at the Foundation of Zaragoza (Spain), consisting of 10 sessions of 45 minutes/week during 10 weeks.

The conceptual framework of this intervention is formed by 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 Aragón (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.

Eligibility criteria: Inclusion Criteria:

* Older adults (age ≥ 65)
* Older people with an MEC between: 28-35 points with or without psychiatric pathology (depression, anxiety)
* Non-Institutionalized People.
* Older people with a Lawton index greater than or equal to 3.

Exclusion Criteria:

* People who have received some type of cognitive stimulation therapy in the last year, that is, people who attend memory or mental activation workshops (in the major centers of the Zaragoza City Council, elderly associations, women's associations, etc. .).
* People who present values of more than 6 points, in the abbreviated Goldberg anxiety scale and also in the Yesavage depression scale, score more than 12/15, due to presenting intense symptoms, which made it difficult to carry out the intervention.

Primary outcomes:
measure: The Spanish versions of the Mini-Mental State Examination (MEC-35)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
Secondary outcomes:
measure: Set Test
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The Barthel Index (Barthel)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The scale of Lawton & Brody (Lawton)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The Goldberg questionnaire (EADG)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
measure: The abbreviated Yesavage depression scale (GDS-15)
timeFrame: baseline and change in 1 week, 6 months, baseline and 12 moths
Other outcomes:
Locations:
Study officials:
References:
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