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NCT Number: NCT03493100

Hohenheim Malnutrition Study in Geriatric Fracture Patients

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.

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Key information

Conditions

Geriatric Patients Fractures, Bone Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Other

The control group will receive treatment according to usual care.

Primary outcomes

  1. 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

  1. Nutritional status

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).

  2. Mobility

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).

  3. Arm/leg circumference

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  4. Extracellular to body cell mass ratio (ECM/BCM - Ratio)

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  5. Skinfold thickness

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  6. Quality of life

    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.

    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.

  7. Comorbidity rate

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  8. Medical condition

    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.

    Difference between intervention and control group at discharge and after 4 weeks.

  9. Sarcopenia prevalence

    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.

    Difference between intervention and control group at discharge and after 4 weeks.

  10. Phase angle

    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.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  11. Routine laboratory tests (serum plasma)

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  12. Vitamin D in serum

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  13. Vitamin B12 in serum

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  14. Folic acid in serum

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  15. CRP (C-reactive protein) in serum

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  16. BCM (body cell mass)

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  17. Body weight

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  18. BMI (body mass index)

    Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.

    Difference between intervention and control group at discharge and after 4 weeks follow-up.

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Acronym: HohMal2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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