NCT05104411

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

25 days

First QC Date

October 22, 2021

Last Update Submit

July 15, 2022

Conditions

Keywords

RehabilitationCritical illnessCoronavirus disease 2019 (COVID-19_Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Recovery of function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change of Appendicular skeletal muscle mass index (ASMI)

    at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

  • Change of Medical Research Council (MRC) sum score

    at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

  • Change of handgrip strength

    at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

  • Change of number of 1-min sit-to-stand

    at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

  • Change of walking speed

    at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion

  • +1 more secondary outcomes

Interventions

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaewon Beom, MD, PhD

    Department of Rehabilitation Medicine, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

August 14, 2021

Primary Completion

September 8, 2021

Study Completion

July 15, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations