Geriatric Patients
Conditions
Keywords
oral nutritional supplementation, geriatrics, bone fracture
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.
Interventions
DIETARY_SUPPLEMENToral nutritional supplementation
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.
OTHERUsual care
The control group will receive treatment according to usual care.
Sponsors
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Germany
Outcome results
None listed