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临床试验/NCT03327935
NCT03327935已完成不适用

Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Loss of lean body mass

研究概览

简要总结

Randomized intervention by nutritional supplements and training in postoperative patients after discharge

详细描述

Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.

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

盲法说明

Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands
  • Aged 18 years or above
  • One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery
  • At nutritional risk according to screening

排除标准

  • Minimally invasive surgery/Laparoscopic surgery
  • Severely reduced kidney function (p-creatinin>250 mikromol/l) or dialysis
  • Terminal illness
  • Inability to cooperate in tests or exercises due to cognitive function or dementia
  • Admitted to intensive care unit
  • Inability to speak or understand Faroese, Danish or English
  • Consent according to national regulations not obtainable

结局指标

主要结局

Loss of lean body mass

时间窗: 8 weeks

Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Rikardt Andersen

Associate professor

University of Copenhagen

研究点 (2)

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