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Clinical Trials/NCT06666088
NCT06666088
Completed
N/A

Program of Cognitive Stimulation and Strength Training on Cognitive Performance and Physical Mobility in Older Adults With Mild Cognitive Impairment

University of Jaén1 site in 1 country81 target enrollmentJanuary 13, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University of Jaén
Enrollment
81
Locations
1
Primary Endpoint
Isaacs test
Status
Completed
Last Updated
last year

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
January 13, 2025
End Date
April 11, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jaén
Responsible Party
Principal Investigator
Principal Investigator

Agustín Aibar Almazán

Principal investigator

University of Jaén

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Body Mass Index (BMI)(Up to twelve weeks)

Study Sites (1)

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