神经(早期)康复者的身体成分对康复成功的影响
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
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
注册 (实际的)
联系人和位置
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
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
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
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
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
一般刊物
- Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
- Stucki G, Cieza A, Geyh S, Battistella L, Lloyd J, Symmons D, Kostanjsek N, Schouten J. ICF Core Sets for rheumatoid arthritis. J Rehabil Med. 2004 Jul;(44 Suppl):87-93. doi: 10.1080/16501960410015470.
- Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.
- Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krahenbuhl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27.
- Elke G, Hartl WH, Kreymann KG, Adolph M, Felbinger TW, Graf T, de Heer G, Heller AR, Kampa U, Mayer K, Muhl E, Niemann B, Rumelin A, Steiner S, Stoppe C, Weimann A, Bischoff SC. [DGEM Guideline "Clinical Nutrition in Critical Care Medicine" - short version]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2019 Jan;54(1):63-73. doi: 10.1055/a-0805-4118. Epub 2019 Jan 8. German.
- Schmidt SB, Boltzmann M, Rollnik JD. Nutritional situation of enterally fed patients in neurological early rehabilitation and impact of nutritional status on functional outcome. Clin Nutr. 2020 Feb;39(2):425-432. doi: 10.1016/j.clnu.2019.02.011. Epub 2019 Feb 10.
- Schmidt SB, Boltzmann M, Krauss JK, Stangel M, Gutenbrunner C, Rollnik JD. Standardized nutritional supply versus individual nutritional assessment: Impact on weight changes, complications and functional outcome from neurological early rehabilitation. Clin Nutr. 2020 Apr;39(4):1225-1233. doi: 10.1016/j.clnu.2019.05.013. Epub 2019 May 16.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
研究美国 FDA 监管的设备产品
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.