Rhythmic Exercise in Older Adults With Cognitive Impairment

NCT06130878 | Completed

• 1 other identifier: -UJAEN
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (9)

• MoCA (Montreal Cognitive Assessment)

  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

• TMT (Trail Making Test)

  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

• 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

• SFT (Senior Fitness Test)

  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.

  Up to twelve weeks

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

  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.

  Up to twelve weeks

• Chair sit and reach test

  To test low back and hamstring flexibility.

  Up to twelve weeks

• Back scratch test

  To measure general shoulder range of motion.

  Up to twelve weeks

• PSQI (Pittsburgh Sleep Quality Index)

  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.

  Up to twelve weeks

• The Yesavage Geriatric Depression Scale

  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.

  Up to twelve weeks

Secondary Outcomes (4)

• Tinetti scale

  Up to twelve weeks

• Frailty phenotype

  Up to twelve weeks

• Handgrip Strength

  Up to twelve weeks

• Mindful Attention Awareness Scale (MAAS)

  Up to twelve weeks

Study Arms (2)

Control Group (CG)

NO INTERVENTION

This group does not receive any treatment.

EXPERIMENTAL GROUP (EG)

EXPERIMENTAL

People assigned to this group will undergo a 12-week physical training intervention

Other: Rhythmic exercise

Interventions

Rhythmic exercise OTHER

A multicomponent rhythmic physical training will be carried out, with a predominance of QMT, following the principles of "Animal Flow" \[46\] and including the following components: wrist mobilizations; activations; specific stretching positions; special locomotor movements or "traveling forms"; interruptions and transitions with dynamic movements and choreographic sequences of "Flow". Aspects related to the control of intensity, volume and progression strategy have yet to be defined.

EXPERIMENTAL GROUP (EG)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

U.E.D. Virgen de la Capilla

Jaén, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: November 8, 2023
• First Posted: November 14, 2023
• Study Start: January 8, 2024
• Primary Completion: January 15, 2024
• Study Completion: April 5, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)