ClinicalTrials.gov
ClinicalTrials.gov Menu

Post - Hospital Syndrome: Profile of Functional Status by Malnutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03126500
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Kristina Norman, Charite University, Berlin, Germany

Brief Summary:
Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

Condition or disease
Malnutrition Sarcopenia

Detailed Description:
The majority of geriatric hospitalized patients are at high risk for malnutrition at discharge, which has negative impact on post-hospital outcomes. In a cross-sectional analysis in malnourished, geriatric patients we will evaluate frailty-status and functional status using objective and subjective methods at hospital discharge. Moreover, we will investigate the association between nutritional Status and frailty, sarcopenia, quality of life and fatigue.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Post-Hospital Syndrome: Evaluation of Functional Status in Malnourished, Geriatric Patients at Hospital Discharge
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Malnourished
malnourished, geriatrics patients at hospital discharge



Primary Outcome Measures :
  1. Functional Parameter: gait speed [ Time Frame: Baseline (hospital discharge) ]
    gait analysis


Secondary Outcome Measures :
  1. Functional Parameter: timed up & go (TUG) time [ Time Frame: Baseline (hospital discharge) ]
    timed up & go (TUG) test

  2. Functional Parameter: stair climbing time [ Time Frame: Baseline (hospital discharge) ]
    stair climbing test

  3. Functional Parameter: Peak expiratory flow rate [ Time Frame: Baseline (hospital discharge) ]
    peak flow meters scale

  4. Strength Parameter: Hand grip strength [ Time Frame: Baseline (hospital discharge) ]
    Hand grip strength measurement

  5. Strength Parameter: Knee extension strength [ Time Frame: Baseline (hospital discharge) ]
    Knee extension strength measurement

  6. Index of quality of life [ Time Frame: Baseline (hospital discharge) ]
    validated questionnaire

  7. Body composition [ Time Frame: Baseline (hospital discharge) ]
    bioelectric impedance Analysis

  8. Frailty-Status [ Time Frame: Baseline (hospital discharge) ]
    Fried criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.
Criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • Informed written consent
  • Existing or risk of malnutrition
  • Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
  • Life expectancy of > 3 months according to treating doctor

Exclusion Criteria:

  • Age < 60 years
  • Lack of informed written consent
  • No risk of malnutrition
  • Low cognitive status according to Mini-Mental State Examination (MMSE < 24 points)
  • Life expectancy of < 3 months according to treating doctor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126500


Contacts
Contact: Kristina Norman, PD Dr. +4930450565139 kristina.norman@charite.de
Contact: Kristina Franz, M.Sc. +4930450565137 kristina.franz@charite.de

Locations
Germany
Charite University, Berlin, Germany Recruiting
Berlin, Germany
Contact: Kristina Norman, PD Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Kristina Norman, PD Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03126500     History of Changes
Other Study ID Numbers: POSTHOSP
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kristina Norman, Charite University, Berlin, Germany:
Malnutrition
Disease-related malnutrition
Frailty
Sarcopenia
Hospital discharge
Geriatrics

Additional relevant MeSH terms:
Malnutrition
Sarcopenia
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms