UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043367
Receipt number R000049469
Scientific Title Rehabilitation in acute COVID-19 patients: Japanese multi-institutional survey
Date of disclosure of the study information 2021/02/20
Last modified on 2022/03/29 14:43:10

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Basic information

Public title

Rehabilitation in acute COVID-19 patients: Japanese multi-institutional survey

Acronym

Rehabilitation in acute COVID-19 patients: Japanese multi-institutional survey

Scientific Title

Rehabilitation in acute COVID-19 patients: Japanese multi-institutional survey

Scientific Title:Acronym

Rehabilitation in acute COVID-19 patients: Japanese multi-institutional survey

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the actual acute rehabilitation intervention of patients with COVID-19 in Japan

Basic objectives2

Others

Basic objectives -Others

To identify the changes of activity of daily living due to rehabilitation intervention

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proportion of rehabilitation interventions by severity of illness in patients with COVID-19

Key secondary outcomes

Changes in FIM-gait score and Food intake LEVEL scale between at the time of admission and discharge


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

16 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients with COVID-19 admitted to six hospitals in Japan between November 2019 and September 2020.

Key exclusion criteria

patients who refused the assessment

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Yuka
Middle name
Last name Yamada

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-5363-3833

Email

yyamada-kmm@umin.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Yamada

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-5363-3833

Homepage URL


Email

yyamada-kmm@umin.ac.jp


Sponsor or person

Institute

Department of Rehabilitation Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

Tel

03-5363-3833

Email

yyamada-kmm@umin.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

2021 Year 02 Month 20 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34896082/

Publication of results

Unpublished


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34896082/

Number of participants that the trial has enrolled

456

Results

Excluding patients who died, the proportion of critical patients who could walk independently at discharge was 63%, and the proportion of those who were able to take
three meals orally at discharge was 90%. Rehabilitation
was provided to 13.4% of all patients, in particular to 58.3% of patients with critical symptoms.

Results date posted

2022 Year 03 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The mean age was 52.7
The proportion of women was 37.7% (n=172).

The number of patients by severity is as follows
Critical; N=60
Severe; N=83
Mild; N=313

Participant flow

Not applicable due to retrospective study

Adverse events

Not applicable due to retrospective study

Outcome measures

Severity of disease was classified as mild, severe, or critical.
Walking ability was assessed using the Functional Independence Measure locomotion item.
The patient's swallowing status was assessed using the
Food Intake Scale.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 05 Month 21 Day

Date of IRB

2020 Year 05 Month 01 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2021 Year 02 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation of changes in ambulatory status and swallowing status at the time of admission and discharge


Management information

Registered date

2021 Year 02 Month 18 Day

Last modified on

2022 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049469


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name