MalnutritionNCT03126500
Post - Hospital Syndrome: Profile of Functional Status by Malnutrition
An observational study of Malnutrition and Sarcopenia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition, Sarcopenia
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University, Berlin, Germany
Berlin
Kristina Norman, PD Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition, Sarcopenia
- Keywords
- Malnutrition, Disease-related malnutrition, Frailty, Sarcopenia, Hospital discharge, Geriatrics
- Medical subject headings
- Malnutrition, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malnourished | malnourished, geriatrics patients at hospital discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Parameter: gait speed
gait analysis
Measured: Baseline (hospital discharge)
Secondary outcomes (8)
Functional Parameter: timed up & go (TUG) time
timed up \& go (TUG) test
Measured: Baseline (hospital discharge)
Functional Parameter: stair climbing time
stair climbing test
Measured: Baseline (hospital discharge)
Functional Parameter: Peak expiratory flow rate
peak flow meters scale
Measured: Baseline (hospital discharge)
Strength Parameter: Hand grip strength
Hand grip strength measurement
Measured: Baseline (hospital discharge)
Strength Parameter: Knee extension strength
Knee extension strength measurement
Measured: Baseline (hospital discharge)
Index of quality of life
validated questionnaire
Measured: Baseline (hospital discharge)
Body composition
bioelectric impedance Analysis
Measured: Baseline (hospital discharge)
Frailty-Status
Fried criteria
Measured: Baseline (hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start31 May 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Norman, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126500
- Sponsor's protocol ID
- POSTHOSP
- Status last verified
- Jan 2020
- First submitted
- 12 Apr 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Hospital Syndrome: Evaluation of Functional Status in Malnourished, Geriatric Patients at Hospital Discharge
- ClinicalTrials.gov ID
- NCT03126500
- Acronym / sponsor ID
- POSTHOSP
- Conditions
- Malnutrition, Sarcopenia
- Keywords
- Malnutrition, Disease-related malnutrition, Frailty, Sarcopenia, Hospital discharge, Geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malnourished | – | –malnourished, geriatrics patients at hospital discharge |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Parameter: gait speed
Time frame: Baseline (hospital discharge)
gait analysis
8 secondary outcomes
Functional Parameter: timed up & go (TUG) time
Time frame: Baseline (hospital discharge)
Functional Parameter: stair climbing time
Time frame: Baseline (hospital discharge)
Functional Parameter: Peak expiratory flow rate
Time frame: Baseline (hospital discharge)
Strength Parameter: Hand grip strength
Time frame: Baseline (hospital discharge)
Strength Parameter: Knee extension strength
Time frame: Baseline (hospital discharge)
Index of quality of life
Time frame: Baseline (hospital discharge)
Body composition
Time frame: Baseline (hospital discharge)
Frailty-Status
Time frame: Baseline (hospital discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Sarcopenia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Norman, PD Dr. (+4930450565139, kristina.norman@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Parameter: gait speed (time frame: Baseline (hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.