NCT03126500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

April 12, 2017

Last Update Submit

January 27, 2020

Conditions

MalnutritionSarcopenia

Keywords

MalnutritionDisease-related malnutritionFrailtySarcopeniaHospital dischargeGeriatrics

Outcome Measures

Primary Outcomes (1)

  • Functional Parameter: gait speed

    gait analysis

    Baseline (hospital discharge)

Secondary Outcomes (8)

  • Functional Parameter: timed up & go (TUG) time

    Baseline (hospital discharge)

  • Functional Parameter: stair climbing time

    Baseline (hospital discharge)

  • Functional Parameter: Peak expiratory flow rate

    Baseline (hospital discharge)

  • Strength Parameter: Hand grip strength

    Baseline (hospital discharge)

  • Strength Parameter: Knee extension strength

    Baseline (hospital discharge)

  • +3 more secondary outcomes

Study Arms (1)

Malnourished

malnourished, geriatrics patients at hospital discharge

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants are assessed upon discharge from the hospital. Only malnourished patients were analyzed.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University, Berlin, Germany

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

MalnutritionSarcopeniaFrailty

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Central Study Contacts

Kristina Norman, PD Dr.

CONTACT

+4930450565139kristina.norman@charite.de

Kristina Franz, M.Sc.

CONTACT

+4930450565137kristina.franz@charite.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 24, 2017

Study Start

May 31, 2017

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)