Hohenheim Malnutrition Study in Geriatric Fracture Patients

Not Applicable

Completed

• Conditions: Geriatric Patients

• Registration Number: NCT03493100
• Lead Sponsor: University of Hohenheim

Brief Summary

The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Study First Submitted: 2017-06-21
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Primary Completion: 2018-04-30
• Study Completion: 2018-10-25
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• age ≥ 75 years, or
• age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
• written informed consent

Exclusion Criteria

• progressive cancer disease
• relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
• insufficient German speech intelligibility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hand grip strength	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	The primary endpoint is the change in muscle functionality of the study groups after 4 weeks by the measurement of hand grip strength using Jamar®-Dynamometer.

Secondary Outcome Measures

Name	Time	Method
Comorbidity rate	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
BCM (body cell mass)	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
BMI (body mass index)	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Arm/leg circumference	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Folic acid in serum	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Nutritional status	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).
Medical condition	Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks.
Routine laboratory tests (serum plasma)	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Vitamin B12 in serum	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Mobility	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).
Skinfold thickness	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Quality of life	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Activity of daily living (ADL) questionnaire and EQ-5-DL questionnaire.
Sarcopenia prevalence	Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks.
Phase angle	Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.
Vitamin D in serum	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
CRP (C-reactive protein) in serum	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Body weight	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.	Difference between intervention and control group at discharge and after 4 weeks follow-up.

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Germany