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Clinical Trials/NCT06130878
NCT06130878
Completed
Not Applicable

Effects of a Rhythmic Exercise Program on the Physical, Mental and Cognitive Performance of Older Adults With Cognitive Impairment.

University of Jaén1 site in 1 country96 target enrollmentJanuary 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University of Jaén
Enrollment
96
Locations
1
Primary Endpoint
TMT (Trail Making Test)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Rhythmic physical exercise is a very promising non-pharmaceutical tool to prevent or reduce cognitive decline that occurs in people sixty years of age or older. The main objective is to determine the effect of a rhythmic exercise program on the physical, mental and cognitive performance of older adults with cognitive impairment. The main variables of the study will be: global cognitive function evaluated by the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA); attention and executive functions evaluated using the Trail Making Test (TMT) part A and B. As secondary variables, the functional abilities evaluated using the Senior Fitness Test (SFT) will be taken into account. Additionally, sociodemographic variables and variables related to health status will be evaluated. These will take into account the quality of sleep evaluated with the Pittsburgh index, the nutritional status evaluated using the Mini Nutritional Assessment-Short Form (MNA-SF) scale, and the Stress and anxiety levels will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21). All variables will be evaluated before the intervention and after it. After the intervention, it is expected that the exercise program will improve the neurocognitive performance, as well as the functional and psychological abilities of older adults.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
April 5, 2024
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

  • Be 60 years old or older
  • Do not participate in any physical exercise program
  • Present physical autonomy to participate in the physical activities required by the study.
  • Present scores of \> 25 on the MMSE
  • Present current affiliation to the social health security system.
  • Sign the informed consent
  • Understand the instructions, programs and protocols of this project.
  • Complete more than 90% of the intervention with exercise.

Exclusion Criteria

  • Present medical contraindications for performing physical tests.
  • Present diseases that limit cognitive performance and physical activity.
  • Present vestibular diseases
  • Present rheumatological diseases that can be exacerbated by stress articulate.
  • Refusing to sign the informed consent

Outcomes

Primary Outcomes

TMT (Trail Making Test)

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.

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.

Chair sit and reach test

Time Frame: Up to twelve weeks

To test low back and hamstring flexibility.

The Yesavage Geriatric Depression Scale

Time Frame: Up to twelve weeks

Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.

MoCA (Montreal Cognitive Assessment)

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.

Back scratch test

Time Frame: Up to twelve weeks

To measure general shoulder range of motion.

SFT (Senior Fitness Test)

Time Frame: Up to twelve weeks

Instrument used to assess functional abilities. It consists of the following tests: muscle strength (upper and lower limbs), aerobic endurance, flexibility (upper and lower limbs) and agility, 6-minute walk test, Sit-to-foot test using a chair (measures flexibility of the lower body, Try to clasp hands behind your back, Try to get up, walk 8 feet and sit back.

The Short Form-36 Health Survey (SF-36)

Time Frame: Up to twelve weeks

Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.

PSQI (Pittsburgh Sleep Quality Index)

Time Frame: Up to twelve weeks

A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.

Secondary Outcomes

  • Frailty phenotype(Up to twelve weeks)
  • Tinetti scale(Up to twelve weeks)
  • Handgrip Strength(Up to twelve weeks)
  • Mindful Attention Awareness Scale (MAAS)(Up to twelve weeks)

Study Sites (1)

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