Rehabilitation in Severely Ill Inpatients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104411
• Other study ID #: B-2108-705-112
• Status: Completed
• Start date: August 14, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 15, 2022
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Rehabilitative intervention
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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Appendicular skeletal muscle mass index (ASMI)	[Kilogram Per Square Meter]	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Secondary	Change of Medical Research Council (MRC) sum score	0~60 score.	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Secondary	Change of handgrip strength	[Lb].	at baseline, immediately after rehabilitation completion, and 1-month after rehabilitation completion
Secondary	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
Secondary	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
Secondary	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