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Prevalence of Sarcopenia in Geriatric Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124575
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Department of Geriatric Medicine FELIX PLATTER

Tracking Information
First Submitted Date October 7, 2019
First Posted Date October 11, 2019
Last Update Posted Date December 2, 2019
Actual Study Start Date September 10, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2019)
  • Presence of Sarcopenia (yes/no) [ Time Frame: Baseline ]
    Using EWGSOP2 cut-off points
  • Muscle quantity, measured by Body Impedance Analysis (kg) [ Time Frame: Baseline ]
  • Hand Grip Strength (kPa) [ Time Frame: Baseline ]
  • Gait Speed (m/s) [ Time Frame: Baseline ]
  • Timed up and go Test (s) [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: October 10, 2019)
  • Presence of Sarcopenia (yes/no) based on the following diagnostic criteria: [ Time Frame: Baseline ]
  • Body Impedance Analysis (kg) [ Time Frame: Baseline ]
    Using EWGSOP2 cut-off points for low muscle quantity
  • Hand Grip Strength (kPa) [ Time Frame: Baseline ]
  • Gait Speed (m/s) [ Time Frame: Baseline ]
  • Timed up and go Test (s) [ Time Frame: Baseline ]
Change History Complete list of historical versions of study NCT04124575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 14, 2019)
  • Mini Mental Status (Score range from 0 to 30 Points; higher scores reflect better cognitive status) [ Time Frame: Baseline ]
  • Nutritional risk Screening (Score range from 0 to 7 Points; higher scores reflect higher risk of malnutrition) [ Time Frame: Baseline ]
  • Geriatric Depression Scale short version (Score range from 0 to 6 Points; higher scores reflect higher risk of depression) [ Time Frame: Baseline ]
  • Functional Independence Measure at Admission (Score range from 18 to 126 Points; higher scores reflect better functionality) [ Time Frame: Baseline ]
  • Calf and Mid-upper arm Circumference (cm) [ Time Frame: Baseline ]
  • Body Mass Index (kg/m^2) [ Time Frame: Baseline ]
    Weight and height will be combined to report Body Mass Index in kg/m^2
Original Secondary Outcome Measures
 (submitted: October 10, 2019)
  • Mini Mental Status (Units on a Scale) [ Time Frame: Baseline ]
  • Nutritional risk Screening (Units on a Scale) [ Time Frame: Baseline ]
  • Geriatric Depression Scale (Units on a Scale) [ Time Frame: Baseline ]
  • Functional Independence measure at Admission (Units on a Scale) [ Time Frame: Baseline ]
  • Calf and Mid-upper arm Circumference (cm) [ Time Frame: Baseline ]
  • Body Mass Index (kg/m^2) [ Time Frame: Baseline ]
    Weight and height will be combined to report Body Mass Index in kg/m^2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Sarcopenia in Geriatric Patients
Official Title Prevalence of Sarcopenia in Patients Admitted to a Swiss University Department of Geriatric Medicine
Brief Summary To assess the prevalence of sarcopenia among inpatients on acute geriatrics and geriatric rehabilitation wards of a Swiss university department of geriatric medicine using the most recent diagnosis definitions from european guidelines.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will be selected by the University Department of Geriatric Medicine FELIX PLATTER
Condition Sarcopenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2019)
350
Original Estimated Enrollment Same as current
Actual Study Completion Date October 30, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- All patients >65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site

Exclusion Criteria:

  • Lack of informed written consent
  • Implanted defibrillation device
  • Acute Sepsis, severe volume overload or dehydration
  • Life expectancy of < 3 months according to treating physician
  • Unremovable bandages
  • Patients in isolation rooms on the ward
  • Measurement is not possible due to organizational reasons
  • Inability to follow the procedures, e.g. due to language problems, psychological disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04124575
Other Study ID Numbers BASEC 2019-01461
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Department of Geriatric Medicine FELIX PLATTER
Study Sponsor University Department of Geriatric Medicine FELIX PLATTER
Collaborators Not Provided
Investigators
Principal Investigator: Dominic K. Bertschi, Dr. University Department of Geriatric Medicine FELIX PLATTER
Study Chair: Caroline Kiss, Dr. University Department of Geriatric Medicine FELIX PLATTER
Study Director: Reto W. Kressig, Prof. Dr. University Department of Geriatric Medicine FELIX PLATTER
PRS Account University Department of Geriatric Medicine FELIX PLATTER
Verification Date November 2019