Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hand grip strength
研究概览
简要总结
This study aim to compare the efficacy of oral nutritional supplementation (ONS) in femoral neck fracture patients undergoing hip arthroplasty compared with placebo. The hypothesis is "Oral nutritional supplement with Beta-hydroxy-beta-methylbutyrate (HMB) can improve muscle strength in femoral neck fracture patients undergoing hip arthroplasty".
Femoral neck fracture patients aged more than 65 years will be enrolled and allocated into 2 groups
- ONS group: Oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake
- Control group: Standard oral intake
Primary outcome is Grip strength, assessed using hand dynamometer on admission and 2, 6, 12 weeks postoperatively.
Secondary outcomes are
- Serum albumin assessed on admission and 2, 6, 12 weeks postoperatively
- Barthel index assessed at 2, 6, 12 weeks postoperatively
- Mini Nutritional Assessment (MNA), Geriatric Nutritional Risk Index (GNRI) assessed at 2, 6, 12 weeks postoperatively
- Length of stay (day)
- Time up and go (TUG), assessed at 2, 6, 12 weeks postoperatively
- Oxford hip score (OHS), assessed at 2, 6, 12 weeks postoperatively
- Complications, rate of readmission, mortality rate assessed until 3 months
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Femoral neck fracture patients undergoing hip arthroplasty (Total hip arthroplasty or bipolar hemiarthroplasty)
- •Age ≥ 65 years
- •American Society of Anesthesiologists (ASA) class I-III
- •Participants understand and consent to the protocol of the trial
排除标准
- •Pathologic fracture or high impact fracture
- •Morbid obesity (Body mass index > 40)
- •Chronic kidney disease (Chronic kidney disease stage > 3b or estimated glomerular filtration rate (eGFR) < 30)
- •Thyroid disease or endrocrinopathy
- •Gastrointestinal intolerance preventing oral supplementation or Malabsorption syndromes
- •Malignancy with radiotherapy or chemotherapy
- •Cognitive disorder
- •Decompensated Liver Disease or Cirrhosis Child-Pugh Class B-C
- •Known allergy/intolerance to milk or other supplement ingredients
研究组 & 干预措施
ONS group
Receive oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake
干预措施: Oral nutritional supplementation (Dietary Supplement)
Control group
Receive standard oral intake
结局指标
主要结局
Hand grip strength
时间窗: 12 weeks postoperatively
Hand grip strength, assess using hand dynamometer
次要结局
- Time up and go (TUG)(2, 6, 12 weeks postoperatively)
- Hand grip strength(2, 6 weeks postoperatively)
- Body weight(2, 6, 12 weeks postoperatively)
- Body mass index (BMI)(2, 6, 12 weeks postoperatively)
- Serum albumin(2, 6, 12 weeks postoperatively)
- Oxford hip score (OHS)(2, 6, 12 weeks postoperatively)
- Barthel index(2, 6, 12 weeks postoperatively)
- Mini Nutritional Assessment (MNA)(2, 6, 12 weeks postoperatively)
- Geriatric Nutritional Risk Index (GNRI)(2, 6, 12 weeks postoperatively)
研究者
Natthasit Wongwarawanith
Principal Investigator
Thammasat University