Cognitive ImpairmentNCT06666088
Cognitive Stimulation and Strength Training in Older Adults With Cognitive Impairment
A study testing Cognitive stimulation and Strength training in people with Cognitive Impairment, run by University of Jaén at 1 site in Spain.
Trial summary
This program focuses on integrating cognitive exercises and strength training for older adults experiencing mild cognitive impairment (MCI). It aims to enhance cognitive functions such as memory, attention, and problem-solving skills through various stimulating activities. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Cognitive stimulation and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2025to 11 Apr 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over 60 years of age.
- Diagnosis of mild cognitive impairment (MCI) confirmed by neuropsychological evaluation or by a health professional.
- Ability to participate in moderate physical activities and perform strength exercises with supervision.
- Willingness and ability to regularly attend sessions of the cognitive stimulation and physical training program.
- Signed informed consent authorization, indicating that they understand and accept the objectives and activities of the program.
Who cannot join
- Diagnosis of moderate or severe dementia or other advanced cognitive impairment that prevents participation in the program.
- Severe or limiting physical conditions, such as heart disease, respiratory disease, or musculoskeletal injuries, that make it impossible to perform strength exercises.
- Psychiatric disorders (such as major depression or schizophrenia) or substance use that affect commitment or ability to follow the program activities.
- Participation in other cognitive stimulation or physical training programs or interventions in parallel, which may interfere with the evaluation of the effects of the program.
- Inability to understand and follow simple instructions, or lack of family or social support to attend the program if necessary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Program of Cognitive Stimulation and Strength Training on Cognitive Performance and Physical Mobility in Older Adults With Mild Cognitive Impairment
This program focuses on integrating cognitive exercises and strength training for older adults experiencing mild cognitive impairment (MCI). It aims to enhance cognitive functions such as memory, attention, and problem-solving skills through various stimulating activities. At the same time, it incorporates strength training exercises to improve muscle mass, balance, and overall physical mobility. By addressing both cognitive and physical aspects of health, the initiative seeks to provide comprehensive benefits that may lead to improved quality of life for older adults with MCI. The research contributes valuable insights into the importance of holistic interventions in mitigating the effects of cognitive decline and promoting physical well-being in this vulnerable population.
- Conditions
- Cognitive Impairment
- Being tested
- Cognitive stimulation and Strength training
- 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 and Strength trainingOther
The experimental group will participate in a 12-week program to enhance cognitive functions and physical strength through twice-weekly sessions of 45 minutes to 1 hour. Cognitive stimulation activities will improve memory, attention, processing speed, and executive functions through memory games, recall exercises, and tasks that promote focus and quick thinking. Each session will be led by a neuropsychology or occupational therapy professional who will tailor activities to individual needs.
Strength training will also occur twice a week, focusing on exercises that strengthen major muscle groups, improve balance, and enhance coordination. Participants will use light weights, resistance bands, and bodyweight exercises, with modifications based on their physical levels. A specialized trainer will supervise the program, progressively adjusting exercise intensity to ensure safety and optimize benefits.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will not participate in the physical or cognitive exercise intervention but will receive general recommendations for comprehensive health care. This includes discussions about the benefits of engaging in physical and cognitive exercise, as well as advice on managing physical and mental health. All proposed physical and mental assessments will be conducted with the control group at the beginning of the study and after 12 weeks. Additionally, during the study period, they will be monitored for any changes in physical activity levels that may occur throughout the intervention. Follow-up will also include tracking nutritional changes, sleep habits, and stress levels. |
| Experimental Group | Experimental | The experimental group will participate in a 12-week program combining cognitive stimulation and strength training, with two sessions per week. Each cognitive session, lasting 45 minutes to 1 hour, will aim to improve memory, attention, processing speed, and executive functions through activities like memory games and problem-solving tasks. A professional in neuropsychology or occupational therapy will lead these sessions, adapting activities to participants' abilities.
Strength training will also be conducted twice a week for 45 minutes to 1 hour, focusing on exercises that strengthen major muscle groups and improve balance and coordination. Participants will use light weights, resistance bands, and bodyweight exercises, tailored to their physical levels. A specialized trainer will oversee the program, adjusting exercise intensity to ensure safety and optimize benefits. Receives: Other: Cognitive stimulation and Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Measured: Up to twelve weeks
Trail Making Test (TMT)
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Measured: Up to twelve weeks
Isaacs test
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Measured: Up to twelve weeks
Mini-Mental State Examination (MMSE)
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Measured: Up to twelve weeks
Tinetti Scale
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
Measured: Up to twelve weeks
The Digit Symbol Substitution Test (DSST)
Cognitive test to assess processing speed presented on a single sheet of paper that requires a subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90-120 seconds, constitutes the score.
Measured: Up to twelve weeks
Handgrip Strength
Dynamometer will be employed to assess hand grip strength.
Measured: Up to twelve weeks
The Chair Stand Test (CST)
It assesses leg strength, specifically the lower limb muscles, by evaluating a person's ability to repeatedly rise from a chair. The participant begins seated in a chair with their feet flat on the floor and their arms crossed over their chest. On command, they must stand up and sit down again as many times as possible in 30 seconds. The total number of repetitions completed is recorded as the test score. A higher number of repetitions indicates better lower limb strength. This test is commonly used to assess the functional capacity and balance of older adults, as leg strength is crucial for performing daily activities such as rising from a chair or walking.
Measured: Up to twelve weeks
Secondary outcomes (1)
Body Mass Index (BMI)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start13 Jan 2025
- Primary completion7 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 81 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
- NCT06666088
- Sponsor's protocol ID
- -University Jaén.
- Status last verified
- Apr 2025
- First submitted
- 28 Oct 2024
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of Cognitive Stimulation and Strength Training on Cognitive Performance and Physical Mobility in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06666088
- Acronym / sponsor ID
- -University Jaén.
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 30 Oct 2024 (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.
This program focuses on integrating cognitive exercises and strength training for older adults experiencing mild cognitive impairment (MCI). It aims to enhance cognitive functions such as memory, attention, and problem-solving skills through various stimulating activities. At the same time, it incorporates strength training exercises to improve muscle mass, balance, and overall physical mobility. By addressing both cognitive and physical aspects of health, the initiative seeks to provide comprehensive benefits that may lead to improved quality of life for older adults with MCI. The research contributes valuable insights into the importance of holistic interventions in mitigating the effects of cognitive decline and promoting physical well-being in this vulnerable population.
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 |
|---|---|---|
| Control Group | No intervention | –The control group will not participate in the physical or cognitive exercise intervention but will receive general recommendations for comprehensive health care. This includes discussions about the benefits of engaging in physical and cognitive exercise, as well as advice on managing physical and mental health. All proposed physical and mental assessments will be conducted with the control group at the beginning of the study and after 12 weeks. Additionally, during the study period, they will be monitored for any changes in physical activity levels that may occur throughout the intervention. Follow-up will also include tracking nutritional changes, sleep habits, and stress levels. |
| Experimental Group | Experimental | Other: Cognitive stimulation and Strength trainingThe experimental group will participate in a 12-week program combining cognitive stimulation and strength training, with two sessions per week. Each cognitive session, lasting 45 minutes to 1 hour, will aim to improve memory, attention, processing speed, and executive functions through activities like memory games and problem-solving tasks. A professional in neuropsychology or occupational therapy will lead these sessions, adapting activities to participants' abilities. Strength training will also be conducted twice a week for 45 minutes to 1 hour, focusing on exercises that strengthen major muscle groups and improve balance and coordination. Participants will use light weights, resistance bands, and bodyweight exercises, tailored to their physical levels. A specialized trainer will oversee the program, adjusting exercise intensity to ensure safety and optimize benefits. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People over 60 years of age.
- Diagnosis of mild cognitive impairment (MCI) confirmed by neuropsychological evaluation or by a health professional.
- Ability to participate in moderate physical activities and perform strength exercises with supervision.
- Willingness and ability to regularly attend sessions of the cognitive stimulation and physical training program.
- Signed informed consent authorization, indicating that they understand and accept the objectives and activities of the program.
Key exclusion criteria (5 listed)
- Diagnosis of moderate or severe dementia or other advanced cognitive impairment that prevents participation in the program.
- Severe or limiting physical conditions, such as heart disease, respiratory disease, or musculoskeletal injuries, that make it impossible to perform strength exercises.
- Psychiatric disorders (such as major depression or schizophrenia) or substance use that affect commitment or ability to follow the program activities.
- Participation in other cognitive stimulation or physical training programs or interventions in parallel, which may interfere with the evaluation of the effects of the program.
- Inability to understand and follow simple instructions, or lack of family or social support to attend the program if necessary.
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 and Strength trainingThe experimental group will participate in a 12-week program to enhance cognitive functions and physical strength through twice-weekly sessions of 45 minutes to 1 hour. Cognitive stimulation activities will improve memory, attention, processing speed, and executive functions through memory games, recall exercises, and tasks that promote focus and quick thinking. Each session will be led by a neuropsychology or occupational therapy professional who will tailor activities to individual needs. Strength training will also occur twice a week, focusing on exercises that strengthen major muscle groups, improve balance, and enhance coordination. Participants will use light weights, resistance bands, and bodyweight exercises, with modifications based on their physical levels. A specialized trainer will supervise the program, progressively adjusting exercise intensity to ensure safety and optimize benefits. | Other | Experimental Group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: Up to twelve weeks
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Trail Making Test (TMT)
Time frame: Up to twelve weeks
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Isaacs test
Time frame: Up to twelve weeks
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Mini-Mental State Examination (MMSE)
Time frame: Up to twelve weeks
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Tinetti Scale
Time frame: Up to twelve weeks
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
The Digit Symbol Substitution Test (DSST)
Time frame: Up to twelve weeks
Cognitive test to assess processing speed presented on a single sheet of paper that requires a subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90-120 seconds, constitutes the score.
Handgrip Strength
Time frame: Up to twelve weeks
Dynamometer will be employed to assess hand grip strength.
The Chair Stand Test (CST)
Time frame: Up to twelve weeks
It assesses leg strength, specifically the lower limb muscles, by evaluating a person's ability to repeatedly rise from a chair. The participant begins seated in a chair with their feet flat on the floor and their arms crossed over their chest. On command, they must stand up and sit down again as many times as possible in 30 seconds. The total number of repetitions completed is recorded as the test score. A higher number of repetitions indicates better lower limb strength. This test is commonly used to assess the functional capacity and balance of older adults, as leg strength is crucial for performing daily activities such as rising from a chair or walking.
1 secondary outcome
Body Mass Index (BMI)
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 22 Apr 2025.
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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 and Strength training in people with 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 5 inclusion and 5 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 22 Apr 2025. 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?
Montreal Cognitive Assessment (MoCA) (time frame: Up to twelve weeks). The study lists 8 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 22 Apr 2025.