Mild Cognitive ImpairmentNCT04663256
Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment
A study testing Cognitive stimulation group in people with Mild Cognitive Impairment and Older People, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Older People
- What is being tested?
- Cognitive stimulation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2021to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- With or without dependency to move.
- People who show mild cognitive impairment.
- That they were able to carry out the different selected questionnaires.
Who cannot join
- People with visual deficit.
- People already enrolled in a cognitive program.
- Score between 24 and 10 in the Mini Cognitive Exam (MEC).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Older People
- Being tested
- Cognitive stimulation group
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation groupOther
Each week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulation Group | Experimental | This group receives physical training based on exercises for cognitive stimulation. Receives: Other: Cognitive stimulation group |
| Control Group | No intervention | This group does not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
Measured: 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.
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
Measured: Baseline-8 weeks
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.
Measured: Baseline-8 weeks
SF-36 (The Short Form-36 Health Survey)
Used extensively for assessing health-related quality of life.
Measured: Baseline-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start11 Jan 2021
- Primary completion5 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663256
- Sponsor's protocol ID
- University of Jaén_2020
- Status last verified
- May 2022
- First submitted
- 15 Nov 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04663256
- Acronym / sponsor ID
- University of Jaén_2020
- Conditions
- Mild Cognitive Impairment, Older People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulation Group | Experimental | Other: Cognitive stimulation groupThis group receives physical training based on exercises for cognitive stimulation. |
| Control Group | No intervention | –This group does not receive any treatment. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- With or without dependency to move.
- People who show mild cognitive impairment.
- That they were able to carry out the different selected questionnaires.
Key exclusion criteria (3 listed)
- People with visual deficit.
- People already enrolled in a cognitive program.
- Score between 24 and 10 in the Mini Cognitive Exam (MEC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stimulation groupEach week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises. | Other | Cognitive Stimulation Group |
Primary outcome
MMSE (mini-mental state examination)
Time frame: Baseline-8 weeks
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.
Time frame: Baseline-8 weeks
Hetero-administered questionnaire used to detect depression in people over 65 years of age.
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.
SF-36 (The Short Form-36 Health Survey)
Time frame: Baseline-8 weeks
Used extensively for assessing health-related quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation group in people with Mild Cognitive Impairment and Older People, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (mini-mental state examination) (time frame: Baseline-8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.