Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in functional independence scores
研究概览
简要总结
Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation.
详细描述
This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization.
The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study.
Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 years and older;
- •Able to tolerate exercise;
- •Barthel Index ≥60;
- •Be able to walk alone or with the aid of a cane, crutch or walkers;
- •Be able to communicate and inform consent to participate in the research.
排除标准
- •Length of stay <5 days;
- •Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician;
- •Present one or more factors:
- •Terminal illness;
- •Myocardial infarction in the last 3 months;
- •Unstable cardiovascular disease;
- •Any type of fracture in the last 3 months, which makes it impossible to carry out the movements;
- •Severe dementia.
结局指标
主要结局
Changes in functional independence scores
时间窗: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
By using the Barthel Index. This tool indicates an individual's ability to perform basic activities of daily living. Scores range from 0 (severe functional dependence) to 100 (functional independence).
Changes in lower limbs functional capacity
时间窗: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
By using the Short Physical Performance Battery (SPPB) the mobility of the lower limbs will be evaluated through static balance tests while standing, walking speed and muscle strength
次要结局
- Muscle thickness(Baseline and after the intervention period (after 7 days))
- Inflammatory markers(Baseline and after the intervention period (after 7 days))
- Muscle quality(Baseline and after the intervention period (after 7 days))
- Maximum dynamic muscle strength of lower limbs(Baseline and after the intervention period (after 7 days))
- Changes in quality of life scores(Baseline and after the intervention period (after 7 days))
- Mortality(Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.)
- Clinical condition(Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.)
- Walking ability(Baseline and after the intervention period (after 7 days))
- Changes in the depressive symptoms scale(Baseline and after the intervention period (after 7 days))
- Handgrip strength(Baseline and after the intervention period (after 7 days))
- Lower limb muscle power(Baseline and after the intervention period (after 7 days))
- Changes in cognitive state(Baseline and after the intervention period (after 7 days))
- Level of agitation, sedation and delirium(Baseline and after the intervention period (after 7 days))
- Changes in executive function(Baseline and after the intervention period (after 7 days))