Cognitive Stimulation and Strength Training in Older Adults With Cognitive Impairment

NCT06666088 | Completed

• 1 other identifier: -University Jaén.
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  Up to twelve weeks

• Handgrip Strength

  Dynamometer will be employed to assess hand grip strength.

  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.

  Up to twelve weeks

Secondary Outcomes (1)

• Body Mass Index (BMI)

  Up to twelve weeks

Study Arms (2)

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.

Other: Cognitive stimulation and Strength training

Interventions

Cognitive stimulation and Strength training OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Juan Miguel Muñoz Perete

Jaén, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: January 13, 2025
• Primary Completion: April 7, 2025
• Study Completion: April 11, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

ES (1)