NCT03493100CompletedNot Applicable
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 enrollmentStarted: September 15, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Hohenheim
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- hand grip strength
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
oral nutritional supplementation
Experimental
This group receives optimized nutritional support, by ONS for a period of four weeks.
Intervention: oral nutritional supplementation (Dietary Supplement)
Control
Other
The control group will receive treatment according to usual care.
Intervention: Usual care (Other)
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
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
Investigators
Study Sites (1)
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