Cognitive Stimulation in Older With Mild Cognitive Impairment

NCT03831061 | Completed

• 1 other identifier: School of Health Sciences
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Randomized Controlled Trial

Keywords

Mild Cognitive Impairment; Elderly; Randomized Controlled Trial; Cognitive Stimulation; Cognitive Intervention

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 (4)

• 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)

Cognitive stimulation

EXPERIMENTAL

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.

Other: Cognitive stimulation

Control group (No intervention)

NO INTERVENTION

There are 68 participants in total. These participants did not receive intervention.

Interventions

Cognitive stimulation OTHER

Cognitive stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Related Publications (19)

• Goldberg DP, Bridges K, Duncan-Jones P, Grayson D. Dimensions of neuroses seen in primary-care settings. Psychol Med. 1987 May;17(2):461-70. doi: 10.1017/s0033291700025022.

  PMID: 3602238 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

• Lobo A, Saz P, Marcos G, Dia JL, De-la-Camara C. The prevalence of dementia and depression in the elderly community in a southern European population. The Zaragoza study. Arch Gen Psychiatry. 1995 Jun;52(6):497-506. doi: 10.1001/archpsyc.1995.03950180083011.

  PMID: 7771920 BACKGROUND

• 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

• Loewen SC, Anderson BA. Reliability of the Modified Motor Assessment Scale and the Barthel Index. Phys Ther. 1988 Jul;68(7):1077-81. doi: 10.1093/ptj/68.7.1077.

  PMID: 3387463 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. doi: 10.1016/j.explore.2004.11.001.

  PMID: 16791967 BACKGROUND

• Monton C, Perez Echeverria MJ, Campos R, Garcia Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish.

  PMID: 8218816 BACKGROUND

• Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.

  PMID: 12904814 BACKGROUND

• Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.

  PMID: 27042901 BACKGROUND

• Roley SS, DeLany JV, Barrows CJ, Brownrigg S, Honaker D, Sava DI, Talley V, Voelkerding K, Amini DA, Smith E, Toto P, King S, Lieberman D, Baum MC, Cohen ES, Cleveland PA, Youngstrom MJ; American Occupational Therapy Association Commission on Practice. Occupational therapy practice framework: domain & practice, 2nd edition. Am J Occup Ther. 2008 Nov-Dec;62(6):625-83. doi: 10.5014/ajot.62.6.625. No abstract available.

  PMID: 19024744 BACKGROUND

• Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.

  PMID: 2760661 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

• Arthur A, Jagger C, Lindesay J, Graham C, Clarke M. Using an annual over-75 health check to screen for depression: validation of the short Geriatric Depression Scale (GDS15) within general practice. Int J Geriatr Psychiatry. 1999 Jun;14(6):431-9.

  PMID: 10398352 RESULT

• 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

• Gomez-Soria I, Andres Esteban EM, Gomez Bruton A, Peralta-Marrupe P. [Long-term effect analysis of a cognitive stimulation program in mild cognitive impairment elderly in Primary Care: A randomized controlled trial]. Aten Primaria. 2021 Aug-Sep;53(7):102053. doi: 10.1016/j.aprim.2021.102053. Epub 2021 Apr 14. Spanish.

  PMID: 33865010 DERIVED

• Gomez-Soria I, Peralta-Marrupe P, Plo F. Cognitive stimulation program in mild cognitive impairment A randomized controlled trial. Dement Neuropsychol. 2020 Apr-Jun;14(2):110-117. doi: 10.1590/1980-57642020dn14-020003.

  PMID: 32595879 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: Clinical Professor

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

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 5, 2019
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2016
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share