- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06666088
Cognitive Stimulation and Strength Training in Older Adults With Cognitive Impairment
Program of Cognitive Stimulation and Strength Training on Cognitive Performance and Physical Mobility in Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jaén, Spain
- Juan Miguel Muñoz Perete
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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
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: Experimental Group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to twelve weeks
|
|
Handgrip Strength
Time Frame: Up to twelve weeks
|
Dynamometer will be employed to assess hand grip strength.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
|
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.
|
Up to twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Up to twelve weeks
|
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
|
Up to twelve weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- -University Jaén.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.