Rehabilitation in Severely Ill Inpatients With COVID-19

Completed

• Conditions: COVID-19

• Registration Number: NCT05104411
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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 Timeline

• Study Start: 2021-08-14
• Primary Completion: 2021-09-08
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-30
• Study First Posted: 2021-11-03
• Status Verified: 2022-07
• Study Completion: 2022-07-15
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Functional Ambulation Classification	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 Outcome Measures

Name	Time	Method
Change of Appendicular skeletal muscle mass index (ASMI)	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion	\[Kilogram Per Square Meter\]
Change of Medical Research Council (MRC) sum score	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion	0\~60 score.
Change of handgrip strength	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion	\[Lb\].
Change of number of 1-min sit-to-stand	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.
Change of walking speed	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.
Change of Berg balance scale	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of