Skip to main content
OpenTrials
Completed

NCT Number: NCT05104411

Rehabilitation in Severely Ill Inpatients With COVID-19

Inpatient rehabilitation of severe-to-critical COVID-19 patients(A longitudinal, single-center retrospective cohort)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

About this study

Patients who underwent intensive care at least two days and classified as severe-to-critical COVID-19 (WHO ordinal scale 5-7) were enrolled. Patients received comprehensive rehabilitation including active exercise program, nutritional support, and psychological support.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

COVID-19 patients who

  • underwent intensive care at least two days,
  • eventually got negative conversion with two consecutive tests,
  • were classified as severe COVID-19 (WHO ordinal scale 5-7) and
  • participated in the inpatient rehabilitation program were included.

Exclusion criteria

COVID-19 patients who died (WHO ordinal scale 8) before discharge were excluded

Treatment and study plan

Rehabilitative intervention

Other

Active rehabilitation programs were done for all patients. Participants were asked to attend exercise program at PT room or bedside. Exercise program was offered once or twice daily on weekdays, by trained kinesiologists. In PT programs, most patients performed strengthening exercise of lower extremities, balance training, sit-up training, sit-to-stand training and gait training for about 30 minutes. Each program was individualized to participants' current physical function. In bedside programs, patients also underwent strengthening exercise and balance training without gait training for about 10 minutes. The duration of exercise program at PT room depends on the patient's condition(upto 1 month).

Primary outcomes

  1. Change of Functional Ambulation Classification

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    0~5 score. FAC 0(Nonfunctional ambulator), FAC1(Ambulator, dependent on physical assistance - Indicates a patient who requires continuous manual contact to support body weight as well as to maintain balance or to assist coordination), FAC 2(Ambulator, dependent on physical assistance - Indicates a patient who requires intermittent or continuous light touch to assist balance or coordination), FAC3(Ambulator, dependent on supervision), FAC4(Ambulator, independent level surface only), FAC5(Ambulator, independent). Higher score means better outcome.

Secondary outcomes

  1. Change of Appendicular skeletal muscle mass index (ASMI)

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    [Kilogram Per Square Meter]

  2. Change of Medical Research Council (MRC) sum score

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    0~60 score.

  3. Change of handgrip strength

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    [Lb].

  4. Change of number of 1-min sit-to-stand

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    Number of repetitions of sit-to-stand within one minute. Higher score means better outcome.

  5. Change of walking speed

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    [meter per second]. Walking speed is measured by 10-meter walking test. If a patient cannot accomplish 10-meter walking test, 4-meter walking test is used instead. Higher score means better outcome.

  6. Change of Berg balance scale

    Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

    0~56 score. Berg balance scale is 14-item objective measure that assesses static balance and fall risk in adults. Each item consists of a five-point ordinal scale(0 to 4), with 0 indicating the lowest level of function and 4 the highest level of function. Higher score means better outcome.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comprehensive Rehabilitation in Severely Ill Inpatients With COVID-19: A Cohort Study in a Tertiary Hospital

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.