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Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment, Older People

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive stimulation group
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • U.E.D. Virgen de la Capilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Stimulation Group

Control Group

Arm Description

This group receives physical training based on exercises for cognitive stimulation.

This group does not receive any treatment.

Outcomes

Primary Outcome Measures

MMSE (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
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.
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
Hamilton Scale for Anxiety.
Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.
SF-36 (The Short Form-36 Health Survey)
Used extensively for assessing health-related quality of life.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2020
Last Updated
May 20, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04663256
Brief Title
Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Each week for 12 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Older People

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Stimulation Group
Arm Type
Experimental
Arm Description
This group receives physical training based on exercises for cognitive stimulation.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group does not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Cognitive stimulation group
Intervention Description
Each week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises.
Primary Outcome Measure Information:
Title
MMSE (mini-mental state examination)
Description
A tool that can be used to systematically and thoroughly assess mental status.
Time Frame
Baseline-8 weeks
Title
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.
Description
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
Time Frame
Baseline-8 weeks
Title
Hamilton Scale for Anxiety.
Description
Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.
Time Frame
Baseline-8 weeks
Title
SF-36 (The Short Form-36 Health Survey)
Description
Used extensively for assessing health-related quality of life.
Time Frame
Baseline-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
U.E.D. Virgen de la Capilla
City
Jaén
ZIP/Postal Code
23330
Country
Spain

12. IPD Sharing Statement

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Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment

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