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

University of Hohenheim1 site in 1 country106 target enrollmentSeptember 15, 2016

ConditionsGeriatric Patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Geriatric Patients
Sponsor: University of Hohenheim
Enrollment: 106
Locations: 1
Primary Endpoint: hand grip strength
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2016

End Date

October 25, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Hohenheim

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

hand grip strength

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.

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 Outcomes

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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)