Cognitive Stimulation Program in Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Stimulation Program in Elderly With Normal Cognition: a Randomized Controlled Trial

Conditions
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Cognitive Change, Randomized Controlled Trial, Occupational Therapy, Aging

Intervention / Treatment
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* Behavioral: Cognitive stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An intervention group and a control group with the same characteristics are included.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group intervention<br>The experimental group consists of 101 participants have been subdivided into two groups of 25/26 that perform the same intervention but on a different day of the week. The two subgroups have received 10 sessions of 45 minutes/week during 10 weeks. Each session included four parts: (a) Reality orientation therapy, (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. . | Behavioral: Cognitive stimulation<br>* The intervention was applied to the experimental group and consisted in 10 sessions of 45 minutes/week during 10 weeks. Each session included four parts: (a) Reality orientation therapy, (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..<br>|
| No Intervention: Group Control<br>The control group consists of 100 participants. The no intervention group did not receive any type of intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Spanish versions of the Mini-Mental State Examination (MEC-35) | It is a reliable and used instrument for the evaluation of cognitive impairment. It meets criteria of feasibility, content validity, procedural and construction. Test-retest reliability: weighted kappa = 0.667, sensitivity = 89.8%, and specificity = 83.9%; with the cutoff point 23/24. A score of 28 is considered the lower limit of normal performance in adult population; scores equal or less than 27 would denote cognitive deficits. | baseline and change in 1 week, 6 months, baseline and 12 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set Test | The set-test was first introduced by Isaacs in 1972, and proposed as an aid in the diagnosis of dementia in the elderly population by Isaacs and Kennie in 1973. It explores verbal fluency, category naming and semantic memory. The collection of information is through a hetero-administered questionnaire. Adapted and validated by Dr. Pascual. It measures the verbal fluency of a categorical type, by asking the subject to cite up to a maximum of ten responses from each of the following categories: colors, animals, fruits and city. There is extensive experience in the use of this scale in our country. It is an option in illiterate people, with sensory impairments or when the consultation time is a conditioning factor. It has a sensitivity of 87% and a specificity of 67%, with a misclassification rate of 24% .The cut-off point to detect dementia: -In adults: Equal to or less than 29 -In older than 65 years: Equal to or less than 27 | baseline and change in 1 week, 6 months, baseline and 12 moths | 
| The Barthel Index (Barthel) | Developed by Mahoney & Barthel (1965), assesses the level of independence in ten Basic Activities of Daily Living (BADLs) and is an indicator of skills for people with reduced mobility. Its internal consistency is 0.89-0.92; obtains intra- observer reliability with kappa indexes between 0.47 to 1.0. Values the ability to perform ten BADLs: feeding, bathing, dressing, grooming, bowel control, bladder control, toilet use, transfers chair-bed, mobility and stairs use. A score is assigned to each item (0, 5, 10, 15) as a function of time and help needed. The final score varies from 0 (completely dependent) to 100 (completely independent). Above 60 points there is a high probability of continuing to live in the community. | baseline and change in 1 week, 6 months, baseline and 12 moths | 
| The scale of Lawton & Brody (Lawton) | Assesses the degree of autonomy in eight Instrumental Activity Daily Livings (IADLs) necessary for living independently in the community. Its reliability is = 0.85 sensitivity = 0.57 and specificity = 0.92. In a study in Spanish population the internal consistency was 0.94; Regarding the convergent validity all the correlation coefficients were higher than 0.40. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men (historically, for men, the areas of food preparation, housekeeping, laundering are excluded). | baseline and change in 1 week, 6 months, baseline and 12 moths | 
| The Goldberg questionnaire (EADG) | Evaluates the mood referred to anxiety and depression. The original questionnaire was developed by Goldberg and consisted of 18 items. Consists of two sub-scales, one of anxiety and other of depression. The last 5 questions of the EADG are only formulated if there are positive answers to the first 4 questions, which are obligatory. The higher the number, the more severe your depression is likely to be. Of all the cutoff points, the most suitable result for the sub-scale of anxiety is 4 points and for the sub-scale of depression is 2 point. The Spanish version of EADG has demonstrated its reliability and validity in the field of Primary Care; with a sensitivity of 83.1%, a specificity of 81.8%, a misclassified index of 17.7% and a positive predictive value of 95.3% . The investigators used the sub-scale of anxiety; its overall specificity = 91% and its sensitivity = 86% | baseline and change in 1 week, 6 months, baseline and 12 moths | 
| The abbreviated Yesavage depression scale (GDS-15) | Evaluates the mood referred to depression. The first version consisted of 30 items . Subsequently, abbreviated version (GDS-15) was published with 15 questions; for use in older people living in the community. For cut-off point 4/5 the sensitivity rates vary between 92.7% and 97.0%, the specificity between 54.8% and 65.2%; the positive predictive value between 69.6% and 82.6% and the negative between 83.3% and 94.4%. | baseline and change in 1 week, 6 months, baseline and 12 moths |