NCT03493100已完成不适用
Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- hand grip strength
研究概览
简要总结
The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.
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
- 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
- •age ≥ 75 years, or
- •age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
- •written informed consent
排除标准
- •progressive cancer disease
- •relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
- •insufficient German speech intelligibility
研究组 & 干预措施
oral nutritional supplementation
Experimental
This group receives optimized nutritional support, by ONS for a period of four weeks.
干预措施: oral nutritional supplementation (Dietary Supplement)
Control
Other
The control group will receive treatment according to usual care.
干预措施: Usual care (Other)
结局指标
主要结局
hand grip strength
时间窗: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
The primary endpoint is the change in muscle functionality of the study groups after 4 weeks by the measurement of hand grip strength using Jamar®-Dynamometer.
次要结局
- Nutritional status(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Comorbidity rate(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- BCM (body cell mass)(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- BMI (body mass index)(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- Arm/leg circumference(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Extracellular to body cell mass ratio (ECM/BCM - Ratio)(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Folic acid in serum(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- Medical condition(Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Routine laboratory tests (serum plasma)(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- Vitamin B12 in serum(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- Mobility(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Skinfold thickness(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Quality of life(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Sarcopenia prevalence(Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Phase angle(Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.)
- Vitamin D in serum(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- CRP (C-reactive protein) in serum(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
- Body weight(Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.)
研究者
研究点 (1)
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