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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.
The control group will receive treatment according to usual care.
University of Hohenheim
Stuttgart, Germany
hand grip strength
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.
Time frame: 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.
Nutritional status
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).
Time frame: 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.
Mobility
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).
Time frame: 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.
Arm/leg circumference
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: 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.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: 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.
Skinfold thickness
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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Time frame: 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.
Quality of life
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.
Time frame: 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.
Comorbidity rate
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: 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.
Medical condition
Difference between intervention and control group at discharge and after 4 weeks.
Time frame: 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.
Sarcopenia prevalence
Difference between intervention and control group at discharge and after 4 weeks.
Time frame: 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.
Phase angle
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: 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.
Routine laboratory tests (serum plasma)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin D in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin B12 in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Folic acid in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
CRP (C-reactive protein) in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BCM (body cell mass)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Body weight
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BMI (body mass index)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.