Effects of a Rhythmic Exercise Program on the Physical, Mental and Cognitive Performance of Older Adults With Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- TMT (Trail Making Test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
TMT (Trail Making Test)
时间窗: 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)
时间窗: 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
时间窗: Up to twelve weeks
To test low back and hamstring flexibility.
The Yesavage Geriatric Depression Scale
时间窗: 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)
时间窗: 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
时间窗: Up to twelve weeks
To measure general shoulder range of motion.
SFT (Senior Fitness Test)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Agustín Aibar Almazán
Principal investigator
University of Jaén