Rhythmic Exercise in Older Adults With Cognitive Impairment

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130878
• Other study ID #: -UJAEN
• Status: Completed
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: April 5, 2024

Study information

• Verified date: May 2024
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 5, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• Rhythmic exercise
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.

Locations

Country	Name	City	State
Spain	U.E.D. Virgen de la Capilla	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Chair sit and reach test	To test low back and hamstring flexibility.	Up to twelve weeks
Primary	Back scratch test	To measure general shoulder range of motion.	Up to twelve weeks
Primary	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
Primary	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	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
Secondary	Frailty phenotype	Five original characteristics are evaluated: involuntary weight loss, self-reported exhaustion, slow gait speed, weakness, and low physical activity.	Up to twelve weeks
Secondary	Handgrip Strength	Dynamometer will be employed to assess hand grip strength.	Up to twelve weeks
Secondary	Mindful Attention Awareness Scale (MAAS)	It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.	Up to twelve weeks