Clinical Trial to Assess the Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Elderly Patients With Spontaneous Hip Fracture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Compare changes in nutritional status between groups based on phase angle
研究概览
简要总结
Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.
详细描述
Hip fracture is a very prevalent pathology in the elderly population. It is estimated that 35-40% of people over 65 suffer a drop per year, and above 75 years this percentage is even higher, with hip fractures being one of the most serious consequences.With regard to malnutrition, the investigators know that aging carries an increased risk of suffering from decreased appetite and intake and changes in body composition. According to different series, the percentage of malnutrition in patients with hip fracture ranges from 13% to 60%. According to the hospital protocols in Spain in elderly people with spontaneous hip fracture, it is important to perform a nutritional screening during the first 24-48 hours of admission, to evaluate their nutritional status and apply a dietary treatment.
The IRENE study aims to determine whether phase angle and reactance, measured by electrical bioimpedance by vector analysis (BIVA) are related to functional recovery in patients with hip fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients over 65 years old.
- •Patients admitted to hospital by spontaneous hip fracture and requiring surgery.
- •Patients who after hip intervention are included in rehabilitation protocols with outpatient rehabilitation plan.
- •Patients who agree to participate by signing informed consent or their regular caregivers grant consent.
排除标准
- •Patients who have a hip fracture from high-impact trauma or secondary to bone pathology (such as neoplasm).
- •Patients with concomitant diseases such as severe hepatic impairment, severe renal impairment, insulin-dependent diabetes melitus and decompensated diabetes mellitus.
- •Patients who require clinical stabilization before surgery beyond 72 hours.
- •Patients receiving emergency surgery.
- •Patients with previous prostheses.
- •Patients with pacemakers.
- •Patients who are not likely to complete the follow-up.
结局指标
主要结局
Compare changes in nutritional status between groups based on phase angle
时间窗: From baseline to month 4
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)
Compare changes in nutritional status between groups based on force measurement
时间窗: From baseline to month 4
Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).
次要结局
- To compare the morphological recovery by muscle ultrasound(From baseline to month 4)
- Compare changes in the ratio RCP/Prealbumin index in the blood analysis(From baseline to month 4)
- To compare the evolution of the Global Subjective Valuation questionnaire(From baseline to month 4)
- Compare changes between groups in the Charlson index(From baseline to month 4)
- Number of participants that have to be readmitted at the hospital.(From baseline to month 4)
- To compare functional recovery(From baseline to month 4)
- Number of participants that die during the study(From baseline to month 4)
- To compare changes in Mini Nutrition Assessment test for aged people(From baseline to month 4)