Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2011-12-01
2015-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group intervention
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.
.
Cognitive stimulation
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..
Group Control
The control group consists of 100 participants. The no intervention group did not receive any type of intervention
No interventions assigned to this group
Interventions
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Cognitive stimulation
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..
Eligibility Criteria
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Inclusion Criteria
* 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 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.
65 Years
ALL
Yes
Sponsors
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Universidad de Zaragoza
OTHER
Responsible Party
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Isabel Gómez-Soria
Principal Investigator
References
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Lobo A, Saz P, Marcos G, Dia JL, de la Camara C, Ventura T, Morales Asin F, Fernando Pascual L, Montanes JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish.
Goldberg D, Bridges K, Duncan-Jones P, Grayson D. Detecting anxiety and depression in general medical settings. BMJ. 1988 Oct 8;297(6653):897-9. doi: 10.1136/bmj.297.6653.897.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
Pascual Millan LF, Martinez Quinones JV, Modrego Pardo P, Mostacero Miguel E, Lopez del Val J, Morales Asin F. [The set-test for diagnosis of dementia]. Neurologia. 1990 Mar;5(3):82-5. Spanish.
Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. doi: 10.5014/ajot.62.1.106.
Vinyoles Bargallo E, Vila Domenech J, Argimon Pallas JM, Espinas Boquet J, Abos Pueyo T, Limon Ramirez E; Los investigadores del proyecto Cuido 1*. [Concordance among Mini-Examen Cognoscitivo and Mini-Mental State Examination in cognitive impairment screening]. Aten Primaria. 2002 Jun 15;30(1):5-13. doi: 10.1016/s0212-6567(02)78956-7. Spanish.
Hanninen T, Koivisto K, Reinikainen KJ, Helkala EL, Soininen H, Mykkanen L, Laakso M, Riekkinen PJ. Prevalence of ageing-associated cognitive decline in an elderly population. Age Ageing. 1996 May;25(3):201-5. doi: 10.1093/ageing/25.3.201.
Novoa AM, Juarez O, Nebot M. [Review of the effectiveness of cognitive interventions in preventing cognitive deterioration in healthy elderly individuals]. Gac Sanit. 2008 Sep-Oct;22(5):474-82. doi: 10.1157/13126930. Spanish.
Duara R, Loewenstein DA, Greig M, Acevedo A, Potter E, Appel J, Raj A, Schinka J, Schofield E, Barker W, Wu Y, Potter H. Reliability and validity of an algorithm for the diagnosis of normal cognition, mild cognitive impairment, and dementia: implications for multicenter research studies. Am J Geriatr Psychiatry. 2010 Apr;18(4):363-70. doi: 10.1097/jgp.0b013e3181c534a0.
Pusswald G, Tropper E, Kryspin-Exner I, Moser D, Klug S, Auff E, Dal-Bianco P, Lehrner J. Health-Related Quality of Life in Patients with Subjective Cognitive Decline and Mild Cognitive Impairment and its Relation to Activities of Daily Living. J Alzheimers Dis. 2015;47(2):479-86. doi: 10.3233/JAD-150284.
Gomez-Soria I, Ferreira C, Olivan-Blazquez B, Aguilar-Latorre A, Calatayud E. Effects of cognitive stimulation program on cognition and mood in older adults, stratified by cognitive levels: A randomized controlled trial. Arch Gerontol Geriatr. 2023 Jul;110:104984. doi: 10.1016/j.archger.2023.104984. Epub 2023 Mar 4.
Gomez-Soria I, Cuenca-Zaldivar JN, Rodriguez-Roca B, Subiron-Valera AB, Salavera C, Marcen-Roman Y, Andrade-Gomez E, Calatayud E. Cognitive Effects of a Cognitive Stimulation Programme on Trained Domains in Older Adults with Subjective Memory Complaints: Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 18;20(4):3636. doi: 10.3390/ijerph20043636.
Other Identifiers
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2
Identifier Type: -
Identifier Source: org_study_id