Mild Cognitive ImpairmentNCT05503641
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
A study testing Cognitive and psychomotor stimulation in people with Mild Cognitive Impairment, run by University of Jaén at 1 site in Spain.
Trial summary
The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive and psychomotor stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2022to 12 Dec 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have a mild dependency according to the Barthel Index (score greater than 60 points).
- Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
- Be able to understand each of the self-administered questionnaires and perform the tests.
Who cannot join
- Have vision problems.
- Be enrolled in a physical exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function and in the Functional Capacity of Older Adults
The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive and psychomotor stimulation
- 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 and psychomotor stimulationOther
Each cognitive stimulation session aimed to maintain and/or improve cognition through memory, language, executive functions, attention, concentration, and perception activities. All the people in the two groups performed the same cognitive stimulation activities adapted to their cognitive and sensory abilities.
The psychomotricity sessions were aimed at maintaining and/or improving the motor, cognitive, social and affective functioning of the person through activities that work on postural tone, body scheme, laterality, fine and gross motor skills, balance, flexibility, among others, adding a cognitive component. All the psychomotricity activities were adapted to the motor and cognitive abilities of the users.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group receives training in cognitive and psychomotricity stimulation activities. Receives: Other: Cognitive and psychomotor stimulation |
| 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.
Tinetti Scale
Scale for the assessment of gait and balance. Indicated for early detection of the risk of falls in the elderly. The higher the score, the lower the risk of falls. The maximum score for the gait subscale is 12, for the balance subscale 16. The sum of both scores for the risk of falls.
Measured: Up to twelve weeks
Handgrip Strength
Dynamometer will be employed to assess handgrip strength.
Measured: Up to twelve weeks
MMSE (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
Measured: Up to twelve weeks
TUG test (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Measured: Up to twelve weeks
The Lawton & Brody scale
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
Measured: Up to twelve weeks
The Barthel Index
Assesses functional dependence when performing basic activities of daily living (BADL), consists of 10 items with scores between 0 and 15 maximum each (Mahoney and Barthel, 1965). The highest possible score is 100 points, this being the greatest independence, if the score is greater than 60 the dependency is slight, if the score is between 40 and 55 the dependency is moderate, when between 20 and 35 points the dependency is serious and if it is less than 20 points the dependency is total.
Measured: Up to twelve weeks
Secondary outcomes (3)
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Measured: Up to twelve weeks
Body Weight
Is the sum of Body Fat and Fat Free Mass.
Measured: Up to twelve weeks
Height
It measures a person's height, measured from the sole of the foot to the top of the head.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start15 Sep 2022
- Primary completion5 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 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
- NCT05503641
- Sponsor's protocol ID
- - University of Jaén
- Status last verified
- Jan 2023
- First submitted
- 13 Aug 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castellote-Caballero Y, Carcelen Fraile MDC, Aibar-Almazan A, Afanador-Restrepo DF, Gonzalez-Martin AM. Effect of combined physical-cognitive training on the functional and cognitive capacity of older people with mild cognitive impairment: a randomized controlled trial. BMC Med. 2024 Jul 8;22(1):281. doi: 10.1186/s12916-024-03469-x.
PubMed 38972988
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function and in the Functional Capacity of Older Adults
- ClinicalTrials.gov ID
- NCT05503641
- Acronym / sponsor ID
- - University of Jaén
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 17 Aug 2022 (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.
The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Cognitive and psychomotor stimulationThis group receives training in cognitive and psychomotricity stimulation activities. |
| Control group | No intervention | –This group does not receive any treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Have a mild dependency according to the Barthel Index (score greater than 60 points).
- Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
- Be able to understand each of the self-administered questionnaires and perform the tests.
Key exclusion criteria (2 listed)
- Have vision problems.
- Be enrolled in a physical exercise program.
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 and psychomotor stimulationEach cognitive stimulation session aimed to maintain and/or improve cognition through memory, language, executive functions, attention, concentration, and perception activities. All the people in the two groups performed the same cognitive stimulation activities adapted to their cognitive and sensory abilities. The psychomotricity sessions were aimed at maintaining and/or improving the motor, cognitive, social and affective functioning of the person through activities that work on postural tone, body scheme, laterality, fine and gross motor skills, balance, flexibility, among others, adding a cognitive component. All the psychomotricity activities were adapted to the motor and cognitive abilities of the users. | Other | Experimental group |
Primary outcome
Tinetti Scale
Time frame: Up to twelve weeks
Scale for the assessment of gait and balance. Indicated for early detection of the risk of falls in the elderly. The higher the score, the lower the risk of falls. The maximum score for the gait subscale is 12, for the balance subscale 16. The sum of both scores for the risk of falls.
Handgrip Strength
Time frame: Up to twelve weeks
Dynamometer will be employed to assess handgrip strength.
MMSE (mini-mental state examination)
Time frame: Up to twelve weeks
A tool that can be used to systematically and thoroughly assess mental status.
TUG test (Timed Up and Go test)
Time frame: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function.
The Lawton & Brody scale
Time frame: Up to twelve weeks
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
The Barthel Index
Time frame: Up to twelve weeks
Assesses functional dependence when performing basic activities of daily living (BADL), consists of 10 items with scores between 0 and 15 maximum each (Mahoney and Barthel, 1965). The highest possible score is 100 points, this being the greatest independence, if the score is greater than 60 the dependency is slight, if the score is between 40 and 55 the dependency is moderate, when between 20 and 35 points the dependency is serious and if it is less than 20 points the dependency is total.
3 secondary outcomes
BMI (Body Mass Index)
Time frame: Up to twelve weeks
Body Weight
Time frame: Up to twelve weeks
Height
Time frame: Up to twelve weeks
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 1 Feb 2023.
- Derived from this study: PubMed 38972988Castellote-Caballero Y, Carcelen Fraile MDC, Aibar-Almazan A, Afanador-Restrepo DF, Gonzalez-Martin AM. Effect of combined physical-cognitive training on the functional and cognitive capacity of older people with mild cognitive impairment: a randomized controlled trial. BMC Med. 2024 Jul 8;22(1):281. doi: 10.1186/s12916-024-03469-x.
- Individual participant dataSharing planned: No
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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 and psychomotor stimulation in people with Mild Cognitive Impairment, 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 2 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 1 Feb 2023. 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?
Tinetti Scale (time frame: Up to twelve weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503641, which also lists 1 linked publication.
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 1 Feb 2023.