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Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663256
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Agustín Aibar Almazán, University of Jaén

Study Description
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Brief Summary:
Mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. That is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Older People Other: Cognitive stimulation group Not Applicable

Detailed Description:
Each week for 8 weeks, GE participants will attend three 60-minute sessions of cognitive exercises. Each session is divided into 10 minutes of memory practice, which includes short-term and long-term memory; 10 minutes of language skills, including vocabulary, comprehension, reading and writing exercises; 10 minutes of calculation, in which arithmetic, similar and different operations are carried out; 10 minutes of praxis and gnosis where drawing and recognition and auditory, tactile, spatial, visual attention were promoted; 10 minutes of orientation where knowledge of space, person and place is developed; and 10 minutes of executive functions in which exercises of organization, planning and problem solving are worked.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Cognitive Stimulation Program on Anxiety, Depression and Quality of Life in People Older Than 70 Years With Mild Cognitive Impairment.
Actual Study Start Date : January 11, 2021
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive Stimulation Group
This group receives physical training based on exercises for cognitive stimulation.
 Other: Cognitive stimulation group
Each week for 8 weeks, GE participants attend three 60-minute sessions of cognitive exercises.
No Intervention: Control Group
This group does not receive any treatment.


Outcome Measures
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Primary Outcome Measures :
  1. MMSE (mini-mental state examination) [ Time Frame: Baseline-8 weeks ]
    A tool that can be used to systematically and thoroughly assess mental status.

  2. Yesavage Geriatric Depression Scale Adjetivo 1 relating to old people, especially with regard to their healthcare. a geriatric hospital Sustantivo 1 an old person, especially one receiving special care. a rest home for geriatrics. [ Time Frame: Baseline-8 weeks ]
    Hetero-administered questionnaire used to detect depression in people over 65 years of age.

  3. Hamilton Scale for Anxiety. [ Time Frame: Baseline-8 weeks ]
    Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.

  4. SF-36 (The Short Form-36 Health Survey) [ Time Frame: Baseline-8 weeks ]
    Used extensively for assessing health-related quality of life.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • With or without dependency to move.
  • People who show mild cognitive impairment.
  • That they were able to carry out the different selected questionnaires.

Exclusion Criteria:

  • People with visual deficit.
  • People already enrolled in a cognitive program.
  • Score between 24 and 10 in the Mini Cognitive Exam (MEC).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663256


Locations
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Spain
U.E.D. Virgen de la Capilla
Jaén, Spain, 23330
Sponsors and Collaborators
University of Jaén
More Information
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Responsible Party: Agustín Aibar Almazán, Principal investigator, University of Jaén
ClinicalTrials.gov Identifier: NCT04663256    
Other Study ID Numbers: University of Jaén_2020
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders