- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663256
Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment
May 20, 2022 updated by: Agustín Aibar Almazán, University of Jaén
Effectiveness of a Cognitive Stimulation Program on Anxiety, Depression and Quality of Life in People Older Than 70 Years With Mild Cognitive Impairment.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jaén, Spain, 23330
- U.E.D. Virgen de la Capilla
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
This group does not receive any treatment.
|
|
|
Experimental: Cognitive Stimulation Group
This group receives physical training based on exercises for cognitive stimulation.
|
Each week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MMSE (mini-mental state examination)
Time Frame: Baseline-8 weeks
|
A tool that can be used to systematically and thoroughly assess mental status.
|
Baseline-8 weeks
|
|
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.
|
Baseline-8 weeks
|
|
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.
|
Baseline-8 weeks
|
|
SF-36 (The Short Form-36 Health Survey)
Time Frame: Baseline-8 weeks
|
Used extensively for assessing health-related quality of life.
|
Baseline-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2021
Primary Completion (Actual)
April 5, 2021
Study Completion (Actual)
April 12, 2021
Study Registration Dates
First Submitted
November 15, 2020
First Submitted That Met QC Criteria
December 4, 2020
First Posted (Actual)
December 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Jaén_2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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