Hohenheim Malnutrition Study in Geriatric Fracture Patients

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status

Conditions
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Geriatric Patients

Intervention / Treatment
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* Dietary Supplement: oral nutritional supplementation
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral nutritional supplementation<br>This group receives optimized nutritional support, by ONS for a period of four weeks. | Dietary Supplement: oral nutritional supplementation<br>* 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.<br>|
| Other: Control<br>The control group will receive treatment according to usual care. | Other: Usual care<br>* The control group will receive treatment according to usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral nutritional supplementation, geriatrics, bone fracture