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临床试验/NCT05474157
NCT05474157终止不适用

Sarcopenia and Related Factors in COVID-19 Following Intensive Care

Koç University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
30
试验地点
1
主要终点
Hand grip strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Hand grip strength

时间窗: 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.

次要结局

  • Calf circumference measurement(12 months)
  • Short form - 36(12 months)
  • SARC-F (Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls)(12 months)
  • Sarcopenia Quality of Life (SarQoL )(12 months)
  • Sit to stand test(12 months)
  • Timed up and go test(12 months)

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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