SarcopeniaNCT05474157
Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care
An observational study of Sarcopenia and Covid19, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to evaluate the patients who had pneumonia or severe acute respiratory distress syndrome (ARDS) due to COVID-19 in terms of sarcopenia and related factors following Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Covid19, Intensive Care Unit Acquired Weakness
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jan 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients with ARDS or severe pneumonia due to COVID-19 hospitalized in intensive care unit, >18 years Study group: 15 Control group: 15
Who may be able to join
- Patients with ARDS or severe pneumonia due to COVID-19 hospitalized in intensive care unit
- > 18 years old
- Age and gender matched patients admitted to the 'Physical Medicine and Rehabilitation' clinic for control group
Who cannot join
- Other diseases that may cause sarcopenia (cancer, non-respiratory organ failure and heart, liver or kidney failure)
- Neurological diseases that may cause sarcopenia (stroke, spinal cord injury, muscle diseases)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
Official title: Sarcopenia and Related Factors in COVID-19 Following Intensive Care
The primary aim of this study is to evaluate the patients who had pneumonia or severe acute respiratory distress syndrome (ARDS) due to COVID-19 in terms of sarcopenia and related factors following Intensive Care Unit (ICU).
The patients who had COVID-19 infection in the ICU and the patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period will be compared in terms of sarcopenia.
Read the detailed description
Patients with acute respiratory distress syndrome (ARDS) could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. Significant muscle loss occurs in the first week of the Intensive Care Unit (ICU) hospitalizations due to acute respiratory failure. Patients lose 18 percent of their body weight when discharged from the ICU. The presence of sepsis is known as the hypercatabolic process for the muscles. Hypophosphatemia and hypomagnesemia can cause respiratory muscle weakness. Fever and inflammation, use of muscle relaxant or sedatives may also cause muscle loss in intensive care during this period.
COVID-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness.
The patients will be evaluated for hand grip strength, calf circumference measurement, 'Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls' (SARCF), SarQoL, timed up and go test, sit to stand test, and Short form-36.
- Conditions
- Sarcopenia, Covid19, Intensive Care Unit Acquired Weakness
- Being tested
- Standard care treatment for COVID-19 in Intensive Care Unit
- Keywords
- Sarcopenia, covid19, acute respiratory distress syndrome, intensive care unit
- Medical subject headings
- Sarcopenia, COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care treatment for COVID-19 in Intensive Care UnitOther
Standard care for ARDS patients consisted of respiratory support, intravenous fluid therapy, medical treatment including anticoagulation and sedation, nutrition, change of position every 4 hours and if needed, hemodynamic support.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 15 patients Patients followed in the Intensive Care Unit due to COVID-19 infection Receives: Other: Standard care treatment for COVID-19 in Intensive Care Unit | |
| Control group | 15 patients Patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients. Hand grip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement. Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg. The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women.
Measured: 12 months
Secondary outcomes (6)
Calf circumference measurement
Calf circumference which positively correlate with appendicular skeletal muscle mass could be used as a surrogate tool of muscle mass for sarcopenia. Adding calf circumference to SARC-F significantly improves the sensitivity and overall diagnostic accuracy of SARC-F in Chinese community dwelling older adults. Calf circumference of the patients was measured while patients in supine position, with left knee raised and calf at right angles to the thigh, using flexible plastic tape at the greatest circumference without compression of the subcutaneous tissue. The measurement were repeated 2 times and average value was recorded. According to 'European Working Group on Sarcopenia in Older People', calf circumference measure on the left leg for right-handed persons in a sitting position with the knee and ankle at a right angle and feet resting on the floor so we measured the left side for sarcopenia.
Measured: 12 months
SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls)
To evaluate sarcopenia SARC-F was applied as a screening questionnaire. It is a self-filled survey questionnaire consisting of five items. The most commonly used criteria for sarcopenia in clinical practice are 'European Working Group on Sarcopenia in Older People' (EWGSOP). EWGSOP recommends using the SARC-F test for risk assessment in patients at risk of sarcopenia. Turkish validation study of the test has been done.
Measured: 12 months
Sit to stand test
Sit to stand test was used to evaluate strength and endurance of lower limbs. Patients are asked to sit on a chair by crossing their hands over their chest. They are asked to sit five times consecutively as fast as possible. The test is started in the sitting position and the test is terminated at the last standing position and the time is recorded. The test is carried out 2 times and the best grade obtained is recorded
Measured: 12 months
Timed up and go test
To assess physical function/performance, timed up and go test was performed. It is an objective, reliable and simple test to evaluate balance and functional movement. The patient is asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time is recorded in how many seconds the patient has finished the test. The test is started and ended when the patient sit on the chair with back supported. It predicts mortality
Measured: 12 months
Sarcopenia Quality of Life (SarQoL )
To evaluate the impact of sarcopenia on quality of life SarQoL was administered. This test identifies and predicts sarcopenia complications that can affect the patient's quality of life. It helps to evaluate the patient's perception of their health, physical, psychological and social aspects to healthcare professional. SarQoL has been found reliable for use in clinical care and research study
Measured: 12 months
Short form - 36
Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Mar 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: techincal reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozden Ozyemisci Taskiran, Prof, Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474157
- Sponsor's protocol ID
- 2020.221.IRB1.071
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was not planned to share individual participant data
Publications
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
PubMed 24108501Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E, Politis P, Koroneos A, Chatzimichail A, Routsi C, Roussos C, Nanas S. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13(5):R161. doi: 10.1186/cc8123. Epub 2009 Oct 8.
PubMed 19814793Rantanen T, Volpato S, Ferrucci L, Heikkinen E, Fried LP, Guralnik JM. Handgrip strength and cause-specific and total mortality in older disabled women: exploring the mechanism. J Am Geriatr Soc. 2003 May;51(5):636-41. doi: 10.1034/j.1600-0579.2003.00207.x.
PubMed 12752838Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
PubMed 31190519Yoo JI, Choi H, Ha YC. Mean Hand Grip Strength and Cut-off Value for Sarcopenia in Korean Adults Using KNHANES VI. J Korean Med Sci. 2017 May;32(5):868-872. doi: 10.3346/jkms.2017.32.5.868.
PubMed 28378563Kawakami R, Murakami H, Sanada K, Tanaka N, Sawada SS, Tabata I, Higuchi M, Miyachi M. Calf circumference as a surrogate marker of muscle mass for diagnosing sarcopenia in Japanese men and women. Geriatr Gerontol Int. 2015 Aug;15(8):969-76. doi: 10.1111/ggi.12377. Epub 2014 Sep 20.
PubMed 25243821Yang M, Hu X, Xie L, Zhang L, Zhou J, Lin J, Wang Y, Li Y, Han Z, Zhang D, Zuo Y, Li Y, Wu L. Screening Sarcopenia in Community-Dwelling Older Adults: SARC-F vs SARC-F Combined With Calf Circumference (SARC-CalF). J Am Med Dir Assoc. 2018 Mar;19(3):277.e1-277.e8. doi: 10.1016/j.jamda.2017.12.016.
PubMed 29477774Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Bahat G, Oren MM, Yilmaz O, Kilic C, Aydin K, Karan MA. Comparing SARC-F with SARC-CalF to Screen Sarcopenia in Community Living Older Adults. J Nutr Health Aging. 2018;22(9):1034-1038. doi: 10.1007/s12603-018-1072-y.
PubMed 30379299Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
PubMed 27716195Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
PubMed 27897430Dodoo-Schittko F, Brandstetter S, Blecha S, Thomann-Hackner K, Brandl M, Knuttel H, Bein T, Apfelbacher C. Determinants of Quality of Life and Return to Work Following Acute Respiratory Distress Syndrome. Dtsch Arztebl Int. 2017 Feb 17;114(7):103-109. doi: 10.3238/arztebl.2017.0103.
PubMed 28302253
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Related Factors in COVID-19 Following Intensive Care
- ClinicalTrials.gov ID
- NCT05474157
- Acronym / sponsor ID
- 2020.221.IRB1.071
- Conditions
- Sarcopenia, Covid19, Intensive Care Unit Acquired Weakness
- Keywords
- Sarcopenia, covid19, acute respiratory distress syndrome, intensive care unit
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: techincal reasons
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 26 Jul 2022 (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.
The primary aim of this study is to evaluate the patients who had pneumonia or severe acute respiratory distress syndrome (ARDS) due to COVID-19 in terms of sarcopenia and related factors following Intensive Care Unit (ICU).
The patients who had COVID-19 infection in the ICU and the patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period will be compared in terms of sarcopenia.
Detailed description
Patients with acute respiratory distress syndrome (ARDS) could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. Significant muscle loss occurs in the first week of the Intensive Care Unit (ICU) hospitalizations due to acute respiratory failure. Patients lose 18 percent of their body weight when discharged from the ICU. The presence of sepsis is known as the hypercatabolic process for the muscles. Hypophosphatemia and hypomagnesemia can cause respiratory muscle weakness. Fever and inflammation, use of muscle relaxant or sedatives may also cause muscle loss in intensive care during this period.
COVID-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness.
The patients will be evaluated for hand grip strength, calf circumference measurement, 'Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls' (SARCF), SarQoL, timed up and go test, sit to stand test, and Short form-36.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Standard care treatment for COVID-19 in Intensive Care Unit15 patients Patients followed in the Intensive Care Unit due to COVID-19 infection |
| Control group | – | –15 patients Patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with ARDS or severe pneumonia due to COVID-19 hospitalized in intensive care unit, >18 years Study group: 15 Control group: 15
Key inclusion criteria (3 listed)
- Patients with ARDS or severe pneumonia due to COVID-19 hospitalized in intensive care unit
- > 18 years old
- Age and gender matched patients admitted to the 'Physical Medicine and Rehabilitation' clinic for control group
Key exclusion criteria (2 listed)
- Other diseases that may cause sarcopenia (cancer, non-respiratory organ failure and heart, liver or kidney failure)
- Neurological diseases that may cause sarcopenia (stroke, spinal cord injury, muscle diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care treatment for COVID-19 in Intensive Care UnitStandard care for ARDS patients consisted of respiratory support, intravenous fluid therapy, medical treatment including anticoagulation and sedation, nutrition, change of position every 4 hours and if needed, hemodynamic support. | Other | Study group |
Primary outcome
Hand grip strength
Time frame: 12 months
Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients. Hand grip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement. Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg. The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women.
6 secondary outcomes
Calf circumference measurement
Time frame: 12 months
SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls)
Time frame: 12 months
Sit to stand test
Time frame: 12 months
Timed up and go test
Time frame: 12 months
Sarcopenia Quality of Life (SarQoL )
Time frame: 12 months
Short form - 36
Time frame: 12 months
Results and safety
The study was stopped early (reason given: techincal reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Results publication: PubMed 24108501Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
- Results publication: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
- Results publication: PubMed 19814793Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E, Politis P, Koroneos A, Chatzimichail A, Routsi C, Roussos C, Nanas S. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13(5):R161. doi: 10.1186/cc8123. Epub 2009 Oct 8.
- Results publication: PubMed 12752838Rantanen T, Volpato S, Ferrucci L, Heikkinen E, Fried LP, Guralnik JM. Handgrip strength and cause-specific and total mortality in older disabled women: exploring the mechanism. J Am Geriatr Soc. 2003 May;51(5):636-41. doi: 10.1034/j.1600-0579.2003.00207.x.
- Results publication: PubMed 31190519Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
- Results publication: PubMed 28378563Yoo JI, Choi H, Ha YC. Mean Hand Grip Strength and Cut-off Value for Sarcopenia in Korean Adults Using KNHANES VI. J Korean Med Sci. 2017 May;32(5):868-872. doi: 10.3346/jkms.2017.32.5.868.
- Results publication: PubMed 25243821Kawakami R, Murakami H, Sanada K, Tanaka N, Sawada SS, Tabata I, Higuchi M, Miyachi M. Calf circumference as a surrogate marker of muscle mass for diagnosing sarcopenia in Japanese men and women. Geriatr Gerontol Int. 2015 Aug;15(8):969-76. doi: 10.1111/ggi.12377. Epub 2014 Sep 20.
- Results publication: PubMed 29477774Yang M, Hu X, Xie L, Zhang L, Zhou J, Lin J, Wang Y, Li Y, Han Z, Zhang D, Zuo Y, Li Y, Wu L. Screening Sarcopenia in Community-Dwelling Older Adults: SARC-F vs SARC-F Combined With Calf Circumference (SARC-CalF). J Am Med Dir Assoc. 2018 Mar;19(3):277.e1-277.e8. doi: 10.1016/j.jamda.2017.12.016.
- Results publication: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Results publication: PubMed 30379299Bahat G, Oren MM, Yilmaz O, Kilic C, Aydin K, Karan MA. Comparing SARC-F with SARC-CalF to Screen Sarcopenia in Community Living Older Adults. J Nutr Health Aging. 2018;22(9):1034-1038. doi: 10.1007/s12603-018-1072-y.
- Results publication: PubMed 27716195Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
- Results publication: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Individual participant dataSharing planned: No. It was not planned to share individual participant data
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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.
Ozden Ozyemisci Taskiran, Prof principal investigator
Koc University School of Medicine
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 and Covid19, run by Koç University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Jul 2022. 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 Turkey (Türkiye). 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 was stopped early (reason given: techincal reasons). Results are not available in the source record.
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?
Hand grip strength (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474157, which also lists 14 linked publications.
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 26 Jul 2022.