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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sarcopenia and Related Factors in COVID-19 Following Intensive Care

Conditions
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Sarcopenia, Covid19, Intensive Care Unit Acquired Weakness

Intervention / Treatment
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* Other: Standard care treatment for COVID-19 in Intensive Care Unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>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<br>* 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.<br>|
| Control group<br>15 patients Patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, Sarcopenia, acute respiratory distress syndrome, intensive care unit