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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral nutritional supplementation | Experimental | This group receives optimized nutritional support, by ONS for a period of four weeks. |
|
| Control | Other | The control group will receive treatment according to usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutritional supplementation | Dietary Supplement | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan C. Bischoff | University of Hohenheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hohenheim | Stuttgart | 70599 | Germany |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Usual care | Other | The control group will receive treatment according to usual care. |
|
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. |