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临床试验/NCT02077491
NCT02077491已完成不适用

The Effect of Protein and Resistance Training on Muscle Mass, Muscle Strength and Functional Ability in Acutely Ill Old Medical Patients; a Randomized Controlled Trial

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Muscle mass (lean mass)

研究概览

简要总结

The purpose of this study is to determine the effect of a high-protein diet during hospitalization in combination with resistance training and a daily protein and energy supplement three months after discharge on the muscle mass, muscle strength, functional ability and weight in acutely ill old medical patients.

详细描述

Intervention:

The interventions during hospitalization and after discharge are undertaken in a standardized manner and have been described in detail in Standardized Operational Procedures. They are summarized in the following.

The Nutritional Intervention during hospitalization aims to reduce loss of muscle mass by supplying sufficient protein to meet the accelerated demands as a consequence of the stress-induced catabolism. The aim of the intervention is to achieve a protein intake of 1.7 g per kg body weight per day. If the body mass index exceeds 30 the body weight corresponding to BMI 30 is used to calculate the aim for protein intake.

On the day of inclusion an individual diet plan is made by an authorized clinical dietitian. Besides covering the high protein requirement the diet plan is calculated to meet the individual requirement for energy, liquids and micronutrients. Energy requirement is estimated individually according to the Nutritional Risk Screening 2002 (Kondrup et al. 2003). This method takes the increased demands during stress metabolism into account. The estimated energy requirement aims for weight maintenance, and not weight gain or loss. The weight is monitored daily during hospitalization, taking into account the loss or gain of edema, to evaluate if the energy intake is balanced with outputs.

The fluid requirement is calculated individually, and considers the reduced ability of the kidney to concentrate urine during stress and that the high protein diet will generate larger amounts of ammonium and urea. Furthermore, patients receive a daily vitamin and mineral tablet.

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
Single (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

入选标准

  • Acutely admitted to Amager Hvidovre Hospital, Copenhagen, Denmark
  • > 65 years
  • Medical patients
  • Understands and speaks Danish
  • Fulfill the criteria's of Systemic Inflammatory Response Syndrome

排除标准

  • Terminal illnesses
  • Glomerular Filtration Rate < 60 ml/min
  • Not able to stand
  • Not able to understand the purpose of the study

结局指标

主要结局

Muscle mass (lean mass)

时间窗: Change from baseline in muscle mass at 3 month after discharge

Whole body Dual-X-ray-Absorptiometry (DXA) scans are used to measure muscle mass. The scanner used is a 'Hologic Discovery A DXA scan'. Quality Control of the DXA scan will be performed and approved before initiating any scans. Before performing DXA scans patients are asked to remove all metal-containing items. If it is not possible to remove all metal-containing items the research assistant will document this. The examination provides information about total muscle mass and allows for analysis of muscle mass on extremities. All analysis will be performed by trained personal.

次要结局

  • Muscle strength(Change from baseline in muscle strength at 3 month after discharge)
  • Functional ability(Change from baseline in functional ability at 3 month after discharge)
  • Body weight(Change from baseline in body weight at 3 month after discharge)
  • Biomarkers(Change from baseline in biomarkers at 3 month after discharge)
  • Bone Mineral Density(Change from baseline in bone mineral density at 3 month after discharge)

研究者

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

Ove Andersen

Head of the Research Center, Medical Doctor

Hvidovre University Hospital

研究点 (2)

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