A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Nutritional parameters
研究概览
简要总结
This is a randomized controlled, observer blinded trial to study the beneficial effect of nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D supplementation whereas the intervention group will receive a moderately high dose protein nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the same rehabilitation program and dietary counseling before discharge. They are followed up 4 weeks after discharge or completion of supplementation. The outcome parameters are nutritional parameters and rehabilitation outcomes.
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
- 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
- •Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment
排除标准
- •Patients who require tube feeding
- •Patients in unstable medical condition
- •Body mass index (BMI) ≧ 25
- •Malignancy
- •Conditions with contraindication for high protein diet
- •Mentally incapacitated and inability to communicate or understand the consent.
结局指标
主要结局
Nutritional parameters
时间窗: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Biochemical and anthropometric measurements
次要结局
- Rehabilitation Outcomes(Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge)