Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Vastus Lateralis Muscle Cross-sectional Area
研究概览
简要总结
This study aims to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission and mortality of hospitalized elderly.
详细描述
Hospitalized elderly people show malnutrition, physical inactivity, and pronounced systemic inflammation which may be exacerbated the catabolic state and promote drastic muscle wasting during the hospitalization and, thus increasing the length of stay, morbidity, and mortality. Therefore, the aim of this study is to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission, and mortality of hospitalized elderly.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sex;
- •65 years and older;
- •hospital stay less than 48 hours;
排除标准
- •cancer in the last 5 years;
- •delirium;
- •cognitive deficit that impossibility the patient to read and sign the informed consent form;
- •neurological disease;
- •neurodegenerative muscular disease;
- •impossibility to receive the intervention.
结局指标
主要结局
Vastus Lateralis Muscle Cross-sectional Area
时间窗: From date of admission until the date of medical discharge. Up to 30 days.
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
次要结局
- Mortality(From date of admission until the date of medical discharge. Up to 30 days.)
- Muscle function(From date of admission until the date of medical discharge. Up to 30 days.)
- Length of hospital stay(From date of admission until the date of medical discharge. Up to 30 days.)
- Nutritional status(From date of admission until the date of medical discharge. Up to 30 days.)
- Handgrip strength(From date of admission until the date of medical discharge. Up to 30 days.)
- Health costs(6 months post-medical discharge)
- Functional independence(From date of admission until the date of medical discharge. Up to 30 days.)
- Hospital readmission post-medical discharge(6 months post-medical discharge)
研究者
Hamilton Augusto Roschel da Silva
Principal Investigator
University of Sao Paulo General Hospital