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临床试验/NCT05639985
NCT05639985已完成不适用

The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

Undine Lehmann, Dr.5 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
550
试验地点
5
主要终点
Body weight

研究概览

简要总结

The aim of the study is to identify the prevalence of malnutrition and sarcopenia in patients admitted in Swiss rehabilitation centers. Furthermore, the aim is to investigate the changes of selected malnutrition and sarcopenia parameters over the length of the rehabilitation stay.

详细描述

The project aims to investigate the prevalence of malnutrition and sarcopenia in the rehabilitation setting. A cross-sectional national multicenter study will be conducted in five rehabilitation centers in Switzerland, including 80 - 130 participants per center for the primary objective (prevalence study). Patients will be screened for malnutrition and sarcopenia with established screening tools and if an elevated risk is observed, diagnosis will be confirmed and severity investigated according to international guidelines. Furthermore, the evolution of selected malnutrition and sarcopenia parameters over the rehabilitation stay should be assessed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients treated in the following groups of rehabilitations will be included:
  • Geriatric rehabilitation
  • Pulmonal rehabilitation
  • Cardiovascular rehabilitation
  • Neurological rehabilitation
  • Musculoskeletal rehabilitation
  • Internistic rehabilitation and oncological rehabilitation
  • Exclusion criteria:
  • Inability to give informed consent
  • Inability to follow study procedures (e.g., due to delirium or language barriers)
  • Expected life expectancy < 3 months and/or palliative care
  • Isolation for example due to Covid-19 infection or tuberculosis
  • Severe dehydration/ volume overload
  • Medical conditions that prevent conducting a Bioelectrical Impedance Analysis (BIA) measurement (e.g. non-removable plasters or bandages at feet or hands) or defibrillator

排除标准

  • 未提供

结局指标

主要结局

Body weight

时间窗: Within 7 days after admission

(in kg)

Height

时间窗: Within 7 days after admission

(in cm)

Prevalence of malnutrition - Risk for malnutrition

时间窗: Within 7 days after admission

The risk for malnutrition will be screened by the Nutritional Risk Screening (NRS-2002, in points). NRS has a scale from 0 to 7 points; higher points indicate a higher risk for malnutrition.

Body Mass Index

时间窗: Within 7 days after admission

(calculated by weight and height in kg/m2)

Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 2

时间窗: Within 7 days after admission

Resistance (in Ohm) and Reactance (in Ohm) measured with BIA are combined with further information on weight, height, sex and age to calculate the appendicular skeletal muscle mass index (in kg/m2)

Weight loss

时间窗: Within 7 days after admission

Weight loss (in percent in six categories - \<5 percent within the last 6 months, 5-10 percent within the last 6 months, \>10 percent within the last 6 months; \<10 percent in more than 6 months, 10 -20 percent in more than 6 months, \>20 percent in more than 6 months)

Reduced energy intake

时间窗: Within 7 days after admission

Reduced energy intake (in percent of intake versus requirement in three categories: less than 50 percent of energy requirement covered for more than 1 week, any reduced energy intake versus requirement for \>2 weeks, no reduced energy intake)

Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 1

时间窗: Within 7 days after admission

Resistance (in Ohm) and Reactance (in Ohm)

Prevalence of malnutrition - Confirmed diagnosis and severity of malnutrition

时间窗: Within 7 days after admission

In case of positive screening, diagnosis of malnutrition will be confirmed and severity assessed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria using the following measures described above: weight (in kg); height (in cm); Body Mass Index (calculated by weight and height in kg/m2); weight loss (in percent in six categories - \<5 percent within the last 6 months, 5-10 percent within the last 6 months, \>10 percent within the last 6 months; \<10 percent in more than 6 months, 10 -20 percent in more than 6 months, \>20 percent in more than 6 months); reduced energy intake (in percent of intake versus requirement in three categories: less than 50 percent of energy requirement covered for more than 1 week, any reduced energy intake versus requirement for \>2 weeks, no reduced energy intake); Bioelectrical impedance analysis for muscle mass: resistance (in Ohm), reactance (in Ohm), Appendicular skeletal muscle mass index (in kg/m2)

Prevalence of malnutrition - overall

时间窗: Calculated through study completion after five months recruitment duration

Overall prevalence of malnutrition will be reported in percent

次要结局

  • Prevalence of sarcopenia - Diagnosis of sarcopenia(Within 7 days after admission)
  • Prevalence of sarcopenia - Risk for sarcopenia by SARC-F(Within 7 days after admission)
  • Prevalence of sarcopenia - Risk for sarcopenia by handgrip strength(Within 7 days after admission)
  • Prevalence of sarcopenia - Risk for sarcopenia(Within 7 days after admission)
  • Prevalence of sarcopenia - Severity of sarcopenia(Within 7 days after admission)
  • Prevalence of sarcopenia - Overall(Calculated through study completion after five months recruitment duration)
  • Changes of handgrip strength between admission and discharge of rehabilitation(At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge))
  • Changes of body weight between admission and discharge of rehabilitation(At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge))
  • Changes of BMI between admission and discharge of rehabilitation(At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge))
  • Changes of Functional Independence Measure between admission and discharge of rehabilitation(At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge))

研究者

发起方
Undine Lehmann, Dr.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Undine Lehmann, Dr.

Lecturer

Bern University of Applied Sciences

研究点 (5)

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