Hohenheim Malnutrition Study in Geriatric Fracture Patients

NCT03493100 | Completed

• 1 other identifier: HohMal2
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Patients

Keywords

oral nutritional supplementation; geriatrics; bone fracture

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (18)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

oral nutritional supplementation

EXPERIMENTAL

This group receives optimized nutritional support, by ONS for a period of four weeks.

Dietary Supplement: oral nutritional supplementation

Control

OTHER

The control group will receive treatment according to usual care.

Other: Usual care

Interventions

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.

oral nutritional supplementation

Usual care OTHER

The control group will receive treatment according to usual care.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 75 years, or
• age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
• written informed consent

You may not qualify if:

• progressive cancer disease
• relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
• insufficient German speech intelligibility

Sponsors & Collaborators

• University of Hohenheim: lead

Study Sites (1)

University of Hohenheim

Stuttgart, 70599, Germany

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephan C. Bischoff

  University of Hohenheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: April 10, 2018
• Study Start: September 15, 2016
• Primary Completion: April 30, 2018
• Study Completion: October 25, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-04

Locations

DE (1)