SarcopeniaNCT04124575
Prevalence of Sarcopenia in Geriatric Patients
An observational study of Sarcopenia, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2019to 30 Oct 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will be selected by the University Department of Geriatric Medicine FELIX PLATTER
Who may be able to join
- All patients >65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Department of Geriatric Medicine FELIX PLATTER
Basel
About this study
Official title: Prevalence of Sarcopenia in Patients Admitted to a Swiss University Department of Geriatric Medicine
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.
- Conditions
- Sarcopenia
- Keywords
- Prevalence, Sarcopenia, Geriatric
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Sarcopenia (yes/no)
Using EWGSOP2 cut-off points
Measured: Baseline
Muscle quantity, measured by Body Impedance Analysis (kg)
Measured: Baseline
Hand Grip Strength (kPa)
Measured: Baseline
Gait Speed (m/s)
Measured: Baseline
Timed up and go Test (s)
Measured: Baseline
Secondary outcomes (6)
Mini Mental Status (Score range from 0 to 30 Points; higher scores reflect better cognitive status)
Measured: Baseline
Nutritional risk Screening (Score range from 0 to 7 Points; higher scores reflect higher risk of malnutrition)
Measured: Baseline
Geriatric Depression Scale short version (Score range from 0 to 6 Points; higher scores reflect higher risk of depression)
Measured: Baseline
Functional Independence Measure at Admission (Score range from 18 to 126 Points; higher scores reflect better functionality)
Measured: Baseline
Calf and Mid-upper arm Circumference (cm)
Measured: Baseline
Body Mass Index (kg/m^2)
Weight and height will be combined to report Body Mass Index in kg/m^2
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start10 Sep 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic K. Bertschi, Dr., Principal investigator, University Department of Geriatric Medicine FELIX PLATTERCaroline Kiss, Dr., Study chair, University Department of Geriatric Medicine FELIX PLATTERReto W. Kressig, Prof. Dr., Study director, University Department of Geriatric Medicine FELIX PLATTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124575
- Sponsor's protocol ID
- BASEC 2019-01461
- Status last verified
- Nov 2019
- First submitted
- 7 Oct 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia in Patients Admitted to a Swiss University Department of Geriatric Medicine
- ClinicalTrials.gov ID
- NCT04124575
- Acronym / sponsor ID
- BASEC 2019-01461
- Conditions
- Sarcopenia
- Keywords
- Prevalence, Sarcopenia, Geriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 11 Oct 2019 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will be selected by the University Department of Geriatric Medicine FELIX PLATTER
Key inclusion criteria (1 listed)
- All patients >65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site
Key exclusion criteria (8 listed)
- 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
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
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- 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.
Dominic K. Bertschi, Dr. principal investigator
University Department of Geriatric Medicine FELIX PLATTER
Caroline Kiss, Dr. study chair
University Department of Geriatric Medicine FELIX PLATTER
Reto W. Kressig, Prof. Dr. study director
University Department of Geriatric Medicine FELIX PLATTER
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 Sarcopenia, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 Dec 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Sarcopenia (yes/no) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 2 Dec 2019.