Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care
NCT ID: NCT05474157
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
30 participants
OBSERVATIONAL
2021-03-01
2022-01-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study group
15 patients Patients followed in the Intensive Care Unit due to COVID-19 infection
Standard care treatment for COVID-19 in Intensive Care Unit
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.
Control group
15 patients Patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period
No interventions assigned to this group
Interventions
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Standard care treatment for COVID-19 in Intensive Care Unit
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.
Eligibility Criteria
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Inclusion Criteria
* \> 18 years old
* Age and gender matched patients admitted to the 'Physical Medicine and Rehabilitation' clinic for control group
Exclusion Criteria
* Neurological diseases that may cause sarcopenia (stroke, spinal cord injury, muscle diseases)
18 Years
ALL
Yes
Sponsors
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Koç University
OTHER
Responsible Party
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Principal Investigators
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Ozden Ozyemisci Taskiran, Prof
Role: PRINCIPAL_INVESTIGATOR
Koc University School of Medicine
Locations
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Koc University School of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Herridge 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.
Gerovasili 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.
Rantanen 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.
Turan 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.
Yoo 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.
Kawakami 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.
Yang 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.
Cruz-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.
Bahat 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.
Beaudart 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.
Podsiadlo 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.
Beaudart 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.
Dodoo-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.
Other Identifiers
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2020.221.IRB1.071
Identifier Type: -
Identifier Source: org_study_id
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