Influence of the Body Composition of Neurological (Early) Rehabilitants on Rehabilitation Success

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurological Rehabilitation
• Intervention / Treatment: Diagnostic test: BIA

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Simone B Schmidt, Dr.; Phone Number: 0049 (0)5152 781 215; Email: si.schmidt@nkho.de

Study Locations

• Germany
  • Lower Saxony
    • Hessisch Oldendorf, Lower Saxony, Germany, 31840
      • Recruiting
      • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
      • Contact: Simone B Schmidt, Dr.; Phone Number: 0049 5152 781 215; Email: si.schmidt@nkho.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; rehabilitants of the phase B, C and D during neurological rehabilitation	Diagnostic test: BIA; Bioelectrical Impedance Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Status	The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.	3 minutes
Disabilities	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	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	The mobility is assed by the Rivermead Mobility Index.	4 minutes
Lenght Of Stay	duration of neurological rehabilitation (in days)	< 1 minute
Mortality	Number of deaths	< 1 minute
Discharge Level	Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)	< 1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioelectrical Impedance	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)	Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).	5 minutes
Mini Nutritional Assessment (MNA)	Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Blood pressure (mmHg) is measured before each BIA measurement.	1 minute
Pulse	Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement.	< 1 minute
Saturation	Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement.	< 1 minute
Body Height	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	Weight (kg) is measured in the morning with clothes but without shoes.	5 minutes
Hip Circumference	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	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	Calf circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).	1 minute

Collaborators and Investigators

• Sponsor: BDH-Klinik Hessisch Oldendorf
• Investigators: Study Director: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessisch Oldendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BIA-Studie

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No