Hohenheim Malnutrition Study in Geriatric Fracture Patients (HohMal2)

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

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 Overview

• Status: Completed
• Conditions: Geriatric Patients
• Intervention / Treatment: Dietary supplement: oral nutritional supplementation; Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70599
    • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral nutritional supplementation; This group receives optimized nutritional support, by ONS for a period of four weeks.	Dietary supplement: oral 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.
Other: Control; The control group will receive treatment according to usual care.	Other: Usual care; The control group will receive treatment according to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).	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	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).	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	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	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.	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	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Difference between intervention and control group at discharge and after 4 weeks.	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	Difference between intervention and control group at discharge and after 4 weeks.	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	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin D in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	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	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Folic acid in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	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	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BCM (body cell mass)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

Collaborators and Investigators

• Sponsor: University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: geriatrics; bone fracture; oral nutritional supplementation
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: HohMal2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No