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

July 25, 2022 updated by: Koç University

Sarcopenia and Related Factors in COVID-19 Following Intensive Care

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34010
        • Koc University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Control group
15 patients Patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short form - 36
Time Frame: 12 months
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
Calf circumference measurement
Time Frame: 12 months
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)
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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 )
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.221.IRB1.071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It was not planned to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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