Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle
研究概览
简要总结
This study is a randomized controlled trial comparing outcomes between geriatric hip fractures who received a commercially available (XR RecoveryTM, Salt Lake City Utah) peri-operative nutritional supplement for three weeks post-operatively to those who receive standard nutritional counseling. The main question it aims to answer is:
- Does supplementation decrease muscle loss via ultrasound measurements of the cross-sectional area of the rectus femoris of the uninjured leg?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female, aged 65 years or older.
- •Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention.
- •Able to provide informed consent.
- •Expected to survive at least 6 months after surgery, with no terminal illness.
排除标准
- •Pre-existing conditions that significantly impair mobility prior to injury.
- •Severe renal or liver impairment.
- •Active treatment with investigational drugs or participation in another clinical trial within the last 30 days.
- •Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders.
- •Allergies to any components of the nutritional supplement being tested.
研究组 & 干预措施
XR™ Recovery Supplement
2 packets of XR Carbohydrate Loading will be administered the evening before surgery and one packet on the day of surgery up to 2 hours prior to the scheduled operating time. Participants will then take the XR™ Recovery Supplement twice daily for three weeks following their surgery.
干预措施: XR™ Recovery Supplement (Dietary Supplement)
XR™ Recovery Supplement
2 packets of XR Carbohydrate Loading will be administered the evening before surgery and one packet on the day of surgery up to 2 hours prior to the scheduled operating time. Participants will then take the XR™ Recovery Supplement twice daily for three weeks following their surgery.
干预措施: XR Carbohydrate Loading Supplement (Dietary Supplement)
Standard nutritional counseling
The control group will receive standard of care nutritional counseling with a registered dietician once during inpatient admission, without the use of the supplement.
结局指标
主要结局
Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle
时间窗: Baseline, Visit 7 (1 year post operation)
Outcome measure will be measured using ultrasound imaging.
次要结局
- Number of wound complications(Visit 5, up to 6 months)
- Length of hospital stay(From admission (visit 1) until discharge (~72 hours post-operation))
- Rate of readmission(Visit 7 (1 year post operation))
- Mortality Rate(Visit 7 (1 year post operation))
- Number of inpatient complications related to the surgical procedure for hip fractures(From admission (visit 1) until discharge (~72 hours post-operation))
- Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score(Baseline, Visit 7 (1 year post operation))