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Clinical Trials/NCT05474157
NCT05474157
Terminated
Not Applicable

Sarcopenia and Related Factors in COVID-19 Following Intensive Care

Koç University1 site in 1 country30 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Koç University
Enrollment
30
Locations
1
Primary Endpoint
Hand grip strength
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
January 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Koç University
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Hand grip strength

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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