Cognitive Stimulation Program in Elderly

NCT04648670 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

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

Conditions

Randomized Controlled Trial; Occupational Therapy; Aging; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Set Test

  baseline and change in 1 week, 6 months, baseline and 12 moths

• The Barthel Index (Barthel)

  baseline and change in 1 week, 6 months, baseline and 12 moths

• The scale of Lawton & Brody (Lawton)

  baseline and change in 1 week, 6 months, baseline and 12 moths

• The Goldberg questionnaire (EADG)

  baseline and change in 1 week, 6 months, baseline and 12 moths

• The abbreviated Yesavage depression scale (GDS-15)

  baseline and change in 1 week, 6 months, baseline and 12 moths

Study Arms (2)

Group intervention

EXPERIMENTAL

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

Group Control

NO INTERVENTION

The control group consists of 100 participants. The no intervention group did not receive any type of intervention

Interventions

Cognitive stimulation BEHAVIORAL

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 intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Related Publications (13)

• 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.

  PMID: 10422057 BACKGROUND

• 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.

  PMID: 3140969 BACKGROUND

• 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.

  PMID: 5349366 BACKGROUND

• 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.

  PMID: 7183759 BACKGROUND

• 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.

  PMID: 2361045 BACKGROUND

• 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.

  PMID: 18254437 BACKGROUND

• 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.

  PMID: 12106573 BACKGROUND

• 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.

  PMID: 8670552 BACKGROUND

• 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.

  PMID: 19000530 BACKGROUND

• 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.

  PMID: 20306566 BACKGROUND

• 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.

  PMID: 26401569 BACKGROUND

• 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.

  PMID: 36921506 DERIVED

• 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.

  PMID: 36834329 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An intervention group and a control group with the same characteristics are included.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2015
• Last Updated: December 3, 2020

Record last verified: 2020-12