Clinical trial NCT06130878: Rhythmic Exercise in Older Adults With Cognitive Impairment
Official title: Effects of a Rhythmic Exercise Program on the Physical, Mental and Cognitive Performance of Older Adults With Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Up to twelve weeks
measure: TMT (Trail Making Test)
timeFrame: Up to twelve weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to twelve weeks
measure: SFT (Senior Fitness Test)
timeFrame: Up to twelve weeks
measure: The Short Form-36 Health Survey (SF-36)
timeFrame: Up to twelve weeks
measure: Chair sit and reach test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: Up to twelve weeks
measure: The Yesavage Geriatric Depression Scale
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: Tinetti scale
timeFrame: Up to twelve weeks
measure: Frailty phenotype
timeFrame: Up to twelve weeks
measure: Handgrip Strength
timeFrame: Up to twelve weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: U.E.D. Virgen de la Capilla
Study officials:
References: