- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126500
Post - Hospital Syndrome: Profile of Functional Status by Malnutrition
January 27, 2020 updated by: Kristina Norman, Charite University, Berlin, Germany
Post-Hospital Syndrome: Evaluation of Functional Status in Malnourished, Geriatric Patients at Hospital Discharge
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
- Recruiting
- Charite University, Berlin, Germany
-
Contact:
- Kristina Norman, PD Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study participants are assessed upon discharge from the hospital.
Only malnourished patients were analyzed.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Malnourished
malnourished, geriatrics patients at hospital discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Parameter: gait speed
Time Frame: Baseline (hospital discharge)
|
gait analysis
|
Baseline (hospital discharge)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Parameter: timed up & go (TUG) time
Time Frame: Baseline (hospital discharge)
|
timed up & go (TUG) test
|
Baseline (hospital discharge)
|
|
Functional Parameter: stair climbing time
Time Frame: Baseline (hospital discharge)
|
stair climbing test
|
Baseline (hospital discharge)
|
|
Functional Parameter: Peak expiratory flow rate
Time Frame: Baseline (hospital discharge)
|
peak flow meters scale
|
Baseline (hospital discharge)
|
|
Strength Parameter: Hand grip strength
Time Frame: Baseline (hospital discharge)
|
Hand grip strength measurement
|
Baseline (hospital discharge)
|
|
Strength Parameter: Knee extension strength
Time Frame: Baseline (hospital discharge)
|
Knee extension strength measurement
|
Baseline (hospital discharge)
|
|
Index of quality of life
Time Frame: Baseline (hospital discharge)
|
validated questionnaire
|
Baseline (hospital discharge)
|
|
Body composition
Time Frame: Baseline (hospital discharge)
|
bioelectric impedance Analysis
|
Baseline (hospital discharge)
|
|
Frailty-Status
Time Frame: Baseline (hospital discharge)
|
Fried criteria
|
Baseline (hospital discharge)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2017
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
April 12, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
January 28, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POSTHOSP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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