Rehabilitation in Severely Ill Inpatients With COVID-19

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Rehabilitative intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe COVID-19 (WHO ordinal scale 5-7) who participated in the inpatient rehabilitation program

Description

Inclusion Criteria:

COVID-19 patients who

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Functional Ambulation Classification	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.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Appendicular skeletal muscle mass index (ASMI)	[Kilogram Per Square Meter]	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of Medical Research Council (MRC) sum score	0~60 score.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of handgrip strength	[Lb].	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of number of 1-min sit-to-stand	Number of repetitions of sit-to-stand within one minute. Higher score means better outcome.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of walking speed	[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.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of Berg balance scale	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.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jaewon Beom, MD, PhD, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Woo H, Lee S, Lee HS, Chae HJ, Jung J, Song MJ, Lim SY, Lee YJ, Cho YJ, Kim ES, Kim HB, Lim JY, Song KH, Beom J. Comprehensive Rehabilitation in Severely Ill Inpatients With COVID-19: A Cohort Study in a Tertiary Hospital. J Korean Med Sci. 2022 Aug 29;37(34):e262. doi: 10.3346/jkms.2022.37.e262.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2021
• Primary Completion (Actual): September 8, 2021
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 30, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Critical illness; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Recovery of function; Coronavirus disease 2019 (COVID-19_
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: B-2108-705-112

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