Body Composition Study in Critically Ill Patients-Extended to COVID-19 (COVID-MUSCLE)

March 25, 2025 updated by: University of Malaya
Muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between COVID-19 and non COVID-19 critically ill patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Given the heightened inflammatory status among COVID-19 critically ill patients, we hypothesized that the rate of skeletal muscle loss is accelerated in this population, and this loss is even more pronounce than the general critically ill patients. We further hypothesized that the increased muscle loss will lead to worse functional outcome (lower muscle strength) in COVID-19 critically ill patients compared with age- and sex-matched non-COVID-19 critically ill patients, as it has been shown that quadriceps thickness is strongly correlated with functional status at ICU discharge. Furthermore, a recent systematic review and meta-analysis in survivors of coronavirus (severe acute respiratory syndrome, SARS or Middle-east respiratory syndrome, MERS, or COVID-19) also demonstrated reduced exercise capacity and quality of life at 6 months after hospitalization or ICU admission

Study Type

Observational

Enrollment (Estimated)

50

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

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Faculty of Medicine, University of Malaya

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 30 COVID-19 ICU patients as per the eligibility criteria will be recruited. A total of 20 non-COVID-19 ICU patients that are matched by age (+/- 10 years old), sex and ventilation mode (mostly will be with lung pathology) will be enrolled to compare their change in muscle mass and muscle strength at hospital discharge with COVID-19 ICU patients.

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Admitted into the ICU due to COVID-19

Exclusion Criteria:

  • Likely to transfer out from the ICU in 24 hours from screening
  • Likely to die in the next 7 days
  • Bedbound prior to hospital admission or bedbound in the hospital for >10 days

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
ICU COVID-19 patients
COVID-19 patients that are admitted into the ICU and fulfilled the eligibility criteria
Other: No Intervention
This is an observational study and involved no intervention
ICU non-COVID-19 patients
Non-COVID-19 patients that are admitted into the ICU matched with ICU COVID-19 patients that are recruited and fulfilled the eligibility criteria
Other: No Intervention
This is an observational study and involved no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rectus Femoris Thickness
Time Frame: Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Change in Rectus Femoris Thickness
Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Rectus Femoris Cross-sectional Area
Time Frame: Change in Rectus Femoris Cross-sectional Area at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Change in Rectus Femoris Cross-sectional Area
Change in Rectus Femoris Cross-sectional Area at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm Muscle Thickness
Time Frame: Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Change in Forearm Muscle Thickness
Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Handgrip Strength
Time Frame: Before Hospital Discharge
BIlateral Handgrip Strength
Before Hospital Discharge
Knee Extension Strength
Time Frame: Before Hospital Discharge
BIlateral Knee Extension Strength
Before Hospital Discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Mortality at day 28 (calculated from the first day of ICU admission)
28-day Mortality
Mortality at day 28 (calculated from the first day of ICU admission)
ICU length of stay
Time Frame: From date of enrolment until the date of discharged from the ICU, assessed up to 60 days
Length of stay in the ICU
From date of enrolment until the date of discharged from the ICU, assessed up to 60 days
Hospital length of stay
Time Frame: From date of enrolment until the date of discharged from the hospital, assessed up to 60 days
Length of stay in the Hospital
From date of enrolment until the date of discharged from the hospital, assessed up to 60 days
Length of Mechanical Ventilation
Time Frame: From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days
Duration of Mechanical Ventilation
From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days

Collaborators and Investigators

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

Sponsor

University of Malaya

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 5, 2021

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019615-7520-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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