Clinical trial NCT05474157: Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care
Official title: Sarcopenia and Related Factors in COVID-19 Following Intensive Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sarcopenia
Covid19
Intensive Care Unit Acquired Weakness
Keywords: Sarcopenia
covid19
acute respiratory distress syndrome
intensive care unit
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hand grip strength
timeFrame: 12 months
Secondary outcomes:
measure: Calf circumference measurement
timeFrame: 12 months
measure: SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls)
timeFrame: 12 months
measure: Sit to stand test
timeFrame: 12 months
measure: Timed up and go test
timeFrame: 12 months
measure: Sarcopenia Quality of Life (SarQoL )
timeFrame: 12 months
measure: Short form - 36
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Koc University School of Medicine
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
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