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 | 2024/09/26 09:12:37 |
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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
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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053866
