Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care

NCT05474157 | Terminated

• 1 other identifier: 2020.221.IRB1.071
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Sarcopenia; Covid19; Intensive Care Unit Acquired Weakness

Keywords

Sarcopenia; covid19; acute respiratory distress syndrome; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Calf circumference measurement

  12 months

• SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls)

  12 months

• Sit to stand test

  12 months

• Timed up and go test

  12 months

• Sarcopenia Quality of Life (SarQoL )

  12 months

Study Arms (2)

Study group

15 patients Patients followed in the Intensive Care Unit due to COVID-19 infection

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

Interventions

Standard care treatment for COVID-19 in Intensive Care Unit OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (14)

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• 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.

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• 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.

  PMID: 12752838 RESULT

• 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.

  PMID: 31190519 RESULT

• 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.

  PMID: 28378563 RESULT

• 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.

  PMID: 25243821 RESULT

• 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.

  PMID: 29477774 RESULT

• 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.

  PMID: 30312372 RESULT

• 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.

  PMID: 30379299 RESULT

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  PMID: 27716195 RESULT

• 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.

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• 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.

  PMID: 27897430 RESULT

• 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.

  PMID: 28302253 RESULT

MeSH Terms

Conditions

Sarcopenia; COVID-19; Respiratory Distress Syndrome

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Ozden Ozyemisci Taskiran, Prof

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: July 26, 2022
• Study Start: March 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)