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临床试验/NCT04204655
NCT04204655进行中(未招募)不适用

Investigation of the Influence of the Body Composition of Neurological (Early) Rehabilitants as Well as Their Change in the Course of Rehabilitation and the Effect on Rehabilitation Success - a Pilot Study

BDH-Klinik Hessisch Oldendorf1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
57
试验地点
1
主要终点
Mobility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • neurological disease

排除标准

  • 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

研究组 & 干预措施

Cohort

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

干预措施: BIA (Diagnostic Test)

结局指标

主要结局

Mobility

时间窗: 4 minutes

The mobility is assed by the Rivermead Mobility Index.

Lenght Of Stay

时间窗: < 1 minute

duration of neurological rehabilitation (in days)

Functional Status

时间窗: 3 minutes

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

Disabilities

时间窗: 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.

Muscle Strenght

时间窗: 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.

Mortality

时间窗: < 1 minute

Number of deaths

Discharge Level

时间窗: < 1 minute

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

次要结局

  • Bioelectrical Impedance(15 minutes)
  • Nutritional Risk Screening (NRS 2002)(5 minutes)
  • Mini Nutritional Assessment (MNA)(5 minutes)

研究者

发起方
BDH-Klinik Hessisch Oldendorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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