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

NCT04204655 | Active Not Recruiting

• 1 other identifier: BIA-Studie
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurological Rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Bioelectrical Impedance

  15 minutes

• Nutritional Risk Screening (NRS 2002)

  5 minutes

• Mini Nutritional Assessment (MNA)

  5 minutes

Other Outcomes (8)

• Blood Pressure

  1 minute

• Pulse

  < 1 minute

• Saturation

  < 1 minute

Study Arms (1)

Cohort

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

Diagnostic Test: BIA

Interventions

BIA DIAGNOSTIC_TEST

Bioelectrical Impedance Analysis

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• neurological disease

You may not qualify if:

• 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

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

Related Publications (7)

• 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.

  PMID: 15370754 BACKGROUND

• 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.

  PMID: 16698132 RESULT

• 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.

  PMID: 18504063 RESULT

• 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.

  PMID: 30620956 RESULT

• 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.

  PMID: 30799195 RESULT

• 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.

  PMID: 31151820 RESULT

• 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.

  PMID: 15370761 RESULT

Study Officials

• Jens D Rollnik, Prof. Dr.

  BDH-Klinik Hessisch Oldendorf

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 19, 2019
• Study Start: November 25, 2019
• Primary Completion: September 25, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

DE (1)