Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physical performance - gait speed
研究概览
简要总结
This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
详细描述
Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 60 years or older
- •admission for physical rehabilitation after surgery for femur fracture
- •informed consent
排除标准
- •Any malignant disease during the last five years
- •Known kidney failure (previous glomerular filtration rate <30 ml/min);
- •Known liver failure (Child B or C)
- •Psychiatric disease
- •Severe cognitive impairment (Mini Mental State Examination <18)
- •Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- •Indications related to the study product:
- •More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
- •More than 500 mg of daily calcium intake from medical sources.
- •Adherence to a high-energy or high-protein diet (up to three months before starting the study)
- •Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)
- •Indication to or ongoing artificial nutrition support
- •Inclusion in other nutrition intervention trials
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
结局指标
主要结局
Physical performance - gait speed
时间窗: 4 weeks
Gait speed at the 10-meter walking test
次要结局
- Body weight(4 weeks)
- Body composition - fat-free mass(4 weeks)
- Body composition - phase angle(4 weeks)
- Body composition - muscle mass(4 weeks)
- Body composition - fat-free mass index(4 weeks)
- Physical performance - Timed Up and Go test(4 weeks)
- Functional status - Barthel(4 weeks)
- Functional status - handgrip strength(4 weeks)
- Calf circumference(4 weeks)
- Modality of discharge(4 weeks)
研究者
Barichella Michela
Study coordinator
ASST Gaetano Pini-CTO