UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047293 |
|---|---|
| Receipt number | R000053866 |
| Scientific Title | Retrospective observational study on the effect of rehabilitation during hospitalization on severely COVID-19 patients |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/09/27 14:28:41 |
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Basic information
Public title
Effects of rehabilitation during hospitalization for severely COVID-19 patients
Acronym
Effects of Rehabilitation on severely COVID-19
Scientific Title
Retrospective observational study on the effect of rehabilitation during hospitalization on severely COVID-19 patients
Scientific Title:Acronym
Effects of Rehabilitation on severely COVID-19
Region
| Japan |
Condition
Condition
Severely COVID-19 patients
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of rehabilitation during hospitalization on severely COVID-19 patients in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function: MRC score, Short physical performance battery (SPPB)
ADL: Intensive Care Unit Mobility Scale, Barthel index, functional status score for the ICU
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with COVID-19
2. Patients over 18 years old
3. Japanese nationals
Key exclusion criteria
1. Patients residing outside the country
2. Patients who have COVID-19 but whose reason for hospitalization is not COVID-19
3. Patients deemed inappropriate as subjects for this study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Yamamoto |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan, 390-8621
TEL
0263372836
syamamoto@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Yamamoto |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan, 390-8621
TEL
0263372836
Homepage URL
syamamoto@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Hospital
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan, 390-8621
Tel
0263372836
syamamoto@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000053866&t
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/11/21/6578
Number of participants that the trial has enrolled
23
Results
The median age of the total 23 patients was 59 years, 73.9% were male, and the median PaO2/FiO2 at admission was 172.0. All physical function and ADL parameters were significantly improved from the time of admission to discharge. Moreover, SPPB at discharge significantly correlated with WBC, C-reactive protein, and a significant trend with PaO2/FiO2 and age. Although the median Barthel index at dis-charge was 90 points, 47% of patients had sarcopenia as defined by an SPPB of <9 points.
Results date posted
| 2025 | Year | 09 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Moderate to severe COVID-19 patients, who had PaO2 below 60 mmHg without oxygen and required ICU management, were admitted to Shinshu University Hospital. As our institution is a tertiary care hospital, all patients are those who are determined to be difficult to manage intensively in secondary care. All patients with COVID-19 had a positive PCR test result for SARS-CoV-2. After admission, the patients were first examined by a rehabilitation physician, followed by respiratory rehabilitation intervention by rehabilitation staff, specifically physical and occupational therapists with expertise in the respiratory system.
Participant flow
A total of 23 patients with COVID-19 were included from February 2020 to September 2021. Among 26 patients enrolled in this study, 23 (88.5%) fulfilled the inclusion criteria and received intensive treatment in the ICU.
Adverse events
In this study, no adverse events such as unplanned extubation, accidental arterial catheter or feeding tube removal, uncontrolled arrhythmia, and falls occurred during physio-therapy. Six patients (26.1%) had desaturation of SpO2 >4% at baseline, and one patient (4.5%) had orthostatic hypotension of SBP >20 mmHg at baseline during rehabilitation. Infection control for COVID-19 among physical therapists is also an important issue, and none of the physical therapists working in the COVID-19 ward were SARS-CoV-2-positive during the study period.
Outcome measures
Rehabilitation staff evaluated the following physical functions and ADLs at hospital admission and discharge:
1. Physical functions
We evaluated the Medical Research Council (MRC) score and short physical performance battery (SPPB) as markers of physical function. The MRC score is a muscle strength assessment with a score of 5 points for shoulder abduction, elbow flexion, wrist dorsiflexion, hip flexion, knee extension, and ankle dorsiflexion, with a total score of 60 points. The SPPB is a multidomain performance assessment that consists of three domains, viz., balance test, standing test, and 4m walk test. Each domain is evaluated on a scale of 4 points, with a total of 12 points.
2. ADLs
The intensive care unit mobility scale (IMS), functional status score for the ICU (FSSICU), and Barthel index were evaluated as indicators of ADLs. The IMS is a simple scale that evaluates ADLs from lying in bed to walking in 10 categories, based on whether the patient is able to do so or not. The FSSICU is a scale that evaluates five domains from turning over to walking on a scale of 7 points depending on the amount of assistance, with a total of 35 points. The Barthel index is a scale that evaluates basic ADLs such as eating, dressing, toileting activities, and bathing according to the amount of assistance, with a total score of 100 points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2022 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053866
