Hohenheim Malnutrition Study in Geriatric Fracture Patients

Not Applicable

Completed

• Conditions: Geriatric Patients
• Interventions: Dietary Supplement: oral nutritional supplementation; Other: Usual care

• 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

Arm && Interventions

Group	Intervention	Description
oral nutritional supplementation	oral nutritional supplementation	This group receives optimized nutritional support, by ONS for a period of four weeks.
Control	Usual care	The control group will receive treatment according to usual care.

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.
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.
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.
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