Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Assessment of surgical complications at 26 weeks
研究概览
简要总结
The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.
详细描述
This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Male or female, aged 65-89 years
- •Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region
- •Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon
- •Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts.
排除标准
- •Patients with open fractures
- •Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection
- •Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies)
- •Decisional impairment
研究组 & 干预措施
Nutritional Supplements
Juven and Centrum Silver 50+ will be administered to this group
干预措施: Juven (Drug)
Nutritional Supplements
Juven and Centrum Silver 50+ will be administered to this group
干预措施: Centrum Silver 50+ (Drug)
结局指标
主要结局
Assessment of surgical complications at 26 weeks
时间窗: 26 weeks (post surgery)
Number of subjects that experienced any complications post surgery
次要结局
- Hospital Readmissions(26 weeks (post surgery))
- Secondary fractures(26 weeks (post surgery))
- Grip strength(Baseline to 26 weeks)
- Quality of Life Survey (Short-form 36 Health (SF-36))(Baseline to 26 weeks)