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神经(早期)康复者的身体成分对康复成功的影响

2026年9月29日 更新者:BDH-Klinik Hessisch Oldendorf

调查神经学(早期)康复者身体成分的影响及其在康复过程中的变化和对康复成功的影响 - 一项试点研究

An optimal nutritional supply is associated with better outcome and recovery. For investigating the influence of the nutritional status and body composition on the course of rehabilitation, bioelectrical impedance analyzes (BIA) should be carried out on neurological (early) rehabilitants during the rehabilitation process.

Possible disturbances, suitable outcome valuesfor evaluation of the rehabilitation success (depending on the rehabilitation phase) as well as the required frequency of the BIA measurements in rehabilitation should be estimated with the help of this pilot study.

研究概览

地位

完全的

条件

干预/治疗

详细说明

An optimal coverage of the required calorie requirement is a basic prerequisite for a speedy recovery. One study reports that almost every fourth patient is malnourished in German hospitals. Malnutrition is in turn associated with more complications, higher mortality and longer length of stay. The current DGEM (Deutsche Gesellschaft für Ernährungsmedizin) guideline "Clinical nutrition in intensive care" recommends a calorie intake of 24 kcal per kg body weight during the acute phase of the disease (days 1 to 7) and an increase of calorie intake to 36 kcal per kg body weight in the convalescence and rehabilitation phase.

In a recent study evaluating the weight profile of neurological, enteric-coated early rehabilitants in rehabilitation, 60.6% of patients had weight loss during rehabilitation. Men were also more likely to lose weight than women. In addition, the caloric care of "underweight patients" had a decisive influence on the neurological outcome (as measured by the early rehab barthel-index(FRBI)). For example, underweight patients who were under-served showed significantly lower improvements in FRBI than underweight patients who were over-served.

In another study, the weight of patients remained stable through the use of a nutritional assessment tool (EAT). Also the gender difference was not confirmed in the group with the EAT. The weight change in the rehabilitation course correlated significantly with the difference between the calculated and the average calories received per day. However, an effect of EAT on the frequency of complications or the neurological outcome could not be demonstrated in this study.

However, as body weight may be affected by water balance (edema) and gastrointestinal complications such as constipation, vomiting and diarrhea, consideration of body weight to check diet / nutrition status alone is insufficient. Qualitative statements such as an increase / decrease in muscle mass can not be made on the basis of the weight data. Therefore, in the planned pilot study body composition will be documented by means of bioelectric impedance analysis (BIA) in neurological (early) rehabilitants during rehabilitation. At the same time, various outcome parameters are to be recorded.

The aim of this pilot study is to identify the number and frequency of BIA measurements required to assess the status of care. On the basis of this data, a study is then to be designed to investigate the success of rehabilitation as a function of nutritional status and muscle mass.

研究类型

观察性的

注册 (实际的)

57

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Lower Saxony
      • Hessisch Oldendorf、Lower Saxony、德国、31840
        • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Included in each case are 15 neurological and neurosurgical (early) rehabilitants of phase B, C and D (45 patients in total) of both sexes aged ≥ 18 years.

描述

Inclusion Criteria:

  • neurological disease

Exclusion Criteria:

  • electrical implant as cardiac pacemaker, medications pumps, defibrillators
  • pregnancy or breastfeeding period
  • take part on another study within the last 30 days
  • spasticity
  • amputation of limbs

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Cohort

rehabilitants of the phase B, C and D during neurological rehabilitation

Bioelectrical Impedance Analysis

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional Status
大体时间:3 minutes

The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.

3 minutes
Disabilities
大体时间:3 minutes

An ICF-Assessment of 20 items is used for determination of disabilities of activities and body functions. The severity of each item is scored from zero ("no impairment") to four ("complete impairment") upon admission and at the end of rehabilitation.

3 minutes
Muscle Strenght
大体时间:3 minutes

The hand force is measured with a hand force dyometer three times on each hand upon admission and at the end of rehabilitation.

3 minutes
Mobility
大体时间:4 minutes

The mobility is assed by the Rivermead Mobility Index.

4 minutes
Lenght Of Stay
大体时间:< 1 minute

duration of neurological rehabilitation (in days)

< 1 minute
Mortality
大体时间:< 1 minute

Number of deaths

< 1 minute
Discharge Level
大体时间:< 1 minute

Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)

< 1 minute

次要结果测量

结果测量
措施说明
大体时间
Bioelectrical Impedance
大体时间:15 minutes

Bioelectrical Impedances for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.

15 minutes
Nutritional Risk Screening (NRS 2002)
大体时间:5 minutes

Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).

5 minutes
Mini Nutritional Assessment (MNA)
大体时间:5 minutes

Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

5 minutes

其他结果措施

结果测量
措施说明
大体时间
Blood Pressure
大体时间:1 minute

Blood pressure (mmHg) is measured before each BIA measurement.

1 minute
Pulse
大体时间:< 1 minute

Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement.

< 1 minute
Saturation
大体时间:< 1 minute

Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement.

< 1 minute
Body Height
大体时间:2 minutes

Height is measured in a standing position with a measuring tape. In the case that the patient is not able to stand, the measurement is performed in a lying position.

2 minutes
Body weight
大体时间:5 minutes

Weight (kg) is measured in the morning with clothes but without shoes.

5 minutes
Hip Circumference
大体时间:1 minute

Hip circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute
Waist Circumference
大体时间:1 minute

Waist circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute
Calf Circumference
大体时间:1 minute

Calf circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Jens D Rollnik, Prof. Dr.、BDH-Klinik Hessisch Oldendorf

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年11月25日

初级完成 (实际的)

2023年9月25日

研究完成 (实际的)

2026年9月29日

研究注册日期

首次提交

2019年12月13日

首先提交符合 QC 标准的

2019年12月16日

首次发布 (实际的)

2019年12月19日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • BIA-Studie

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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