COVID-19NCT05104411
Rehabilitation in Severely Ill Inpatients With COVID-19
An observational study of COVID-19, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Inpatient rehabilitation of severe-to-critical COVID-19 patients(A longitudinal, single-center retrospective cohort) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Rehabilitative intervention
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2021to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Severe COVID-19 (WHO ordinal scale 5-7) who participated in the inpatient rehabilitation program
Who may be able to join
- 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.
Who cannot join
- COVID-19 patients who died (WHO ordinal scale 8) before discharge were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- COVID-19
- Being tested
- Rehabilitative intervention
- Keywords
- Rehabilitation, Critical illness, Coronavirus disease 2019 (COVID-19_, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Recovery of function
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitative interventionOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Secondary outcomes (6)
Change of Appendicular skeletal muscle mass index (ASMI)
[Kilogram Per Square Meter]
Measured: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of Medical Research Council (MRC) sum score
0~60 score.
Measured: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of handgrip strength
[Lb].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start14 Aug 2021
- Primary completion8 Sep 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaewon Beom, Seoul National University Bundang Hospital
- Investigators
- Jaewon Beom, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104411
- Sponsor's protocol ID
- B-2108-705-112
- Status last verified
- Jul 2022
- First submitted
- 22 Oct 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36038958
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Rehabilitation in Severely Ill Inpatients With COVID-19: A Cohort Study in a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT05104411
- Acronym / sponsor ID
- B-2108-705-112
- Conditions
- COVID-19
- Keywords
- Rehabilitation, Critical illness, Coronavirus disease 2019 (COVID-19_, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Recovery of function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Severe COVID-19 (WHO ordinal scale 5-7) who participated in the inpatient rehabilitation program
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- COVID-19 patients who died (WHO ordinal scale 8) before discharge were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitative interventionActive 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). | Other | – |
Primary outcome
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.
6 secondary outcomes
Change of Appendicular skeletal muscle mass index (ASMI)
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of Medical Research Council (MRC) sum score
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of handgrip strength
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of number of 1-min sit-to-stand
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of walking speed
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Change of Berg balance scale
Time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 36038958Woo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaewon Beom, MD, PhD principal investigator
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Functional Ambulation Classification (time frame: at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.