リハビリテーションの成功に対する神経学的(早期)リハビリテーション薬の体組成の影響
神経学的(早期)リハビリテーション療法士の身体組成の影響、およびリハビリテーションの過程における変化とリハビリテーションの成功への影響の調査 - パイロットスタディ
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Lower Saxony
-
Hessisch Oldendorf、Lower Saxony、ドイツ、31840
- Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Cohort
rehabilitants of the phase B, C and D during neurological rehabilitation |
Bioelectrical Impedance Analysis |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Status
時間枠:3 minutes
|
The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation. |
3 minutes
|
|
Disabilities
時間枠: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
時間枠: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
時間枠:4 minutes
|
The mobility is assed by the Rivermead Mobility Index. |
4 minutes
|
|
Lenght Of Stay
時間枠:< 1 minute
|
duration of neurological rehabilitation (in days) |
< 1 minute
|
|
Mortality
時間枠:< 1 minute
|
Number of deaths |
< 1 minute
|
|
Discharge Level
時間枠:< 1 minute
|
Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital) |
< 1 minute
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bioelectrical Impedance
時間枠: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)
時間枠:5 minutes
|
Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002). |
5 minutes
|
|
Mini Nutritional Assessment (MNA)
時間枠:5 minutes
|
Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA). |
5 minutes
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Pressure
時間枠:1 minute
|
Blood pressure (mmHg) is measured before each BIA measurement. |
1 minute
|
|
Pulse
時間枠:< 1 minute
|
Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement. |
< 1 minute
|
|
Saturation
時間枠:< 1 minute
|
Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement. |
< 1 minute
|
|
Body Height
時間枠: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
時間枠:5 minutes
|
Weight (kg) is measured in the morning with clothes but without shoes. |
5 minutes
|
|
Hip Circumference
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
- スタディディレクター:Jens D Rollnik, Prof. Dr.、BDH-Klinik Hessisch Oldendorf
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BIA-Studie
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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