Clinical trial NCT03493100: Hohenheim Malnutrition Study in Geriatric Fracture Patients
Official title: Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Patients
Keywords: oral nutritional supplementation
geriatrics
bone fracture
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 106
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: hand grip strength
timeFrame: 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 outcomes:
measure: Nutritional status
timeFrame: 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: Mobility
timeFrame: 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: Arm/leg circumference
timeFrame: 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: Extracellular to body cell mass ratio (ECM/BCM - Ratio)
timeFrame: 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: Skinfold thickness
timeFrame: 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: Quality of life
timeFrame: 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: Comorbidity rate
timeFrame: 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: Medical condition
timeFrame: 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: Sarcopenia prevalence
timeFrame: 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: Phase angle
timeFrame: 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: Routine laboratory tests (serum plasma)
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: Vitamin D in serum
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: Vitamin B12 in serum
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: Folic acid in serum
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: CRP (C-reactive protein) in serum
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: BCM (body cell mass)
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: Body weight
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
measure: BMI (body mass index)
timeFrame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: University of Hohenheim
name: Stephan C. Bischoff
role: PRINCIPAL_INVESTIGATOR
References: