Clinical trial NCT05104411: Rehabilitation in Severely Ill Inpatients With COVID-19
Official title: Comprehensive Rehabilitation in Severely Ill Inpatients With COVID-19: A Cohort Study in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Rehabilitation
Critical illness
Coronavirus disease 2019 (COVID-19_
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Recovery of function
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe COVID-19 (WHO ordinal scale 5-7) who participated in the inpatient rehabilitation program

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Functional Ambulation Classification
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Secondary outcomes:
measure: Change of Appendicular skeletal muscle mass index (ASMI)
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
measure: Change of Medical Research Council (MRC) sum score
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
measure: Change of handgrip strength
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
measure: Change of number of 1-min sit-to-stand
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
measure: Change of walking speed
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
measure: Change of Berg balance scale
timeFrame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
name: Jaewon Beom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.