UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045578 |
|---|---|
| Receipt number | R000051988 |
| Scientific Title | Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2026/04/01 15:30:27 |
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Basic information
Public title
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Acronym
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Scientific Title
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Scientific Title:Acronym
Long-term functional prognostic study of Coronavirus disease - 2019 (COVID-19) infection
Region
| Japan |
Condition
Condition
Coronavirus disease - 2019(COVID-19) infection
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the dysfunction (respiration, mental and physical function) caused by COVID-19 infection for one year, and to clarify the relationship between the duration and severity of the disorder.
Basic objectives2
Others
Basic objectives -Others
Patients with COVID-19 infection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance at hospital discharge, and 1 month, 3 months, 6 months, and 1 year after discharge
Key secondary outcomes
Social regression, health-related QOL, cognitive function, mental status, muscle strength, MRS score, O2 inhalation, gait speed
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients
Key exclusion criteria
Inability to walk before admission, patients diagnosed with the cognitive disorder before admission, patients diagnosed with the psychological disease before admission.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Koike |
Organization
Kitasato university hospital
Division name
Intensive care center
Zip code
2520329
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
0427788111
tkoike@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Koike |
Organization
Kitasato university hospital
Division name
Intensive care center
Zip code
2520329
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
0427788111
Homepage URL
tkoike@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Kitasato university
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
Kitasato University Medical Ethics Organization(KMEO)
Address
Kitasato 1-15-1, Minami-ku, Sagamihara city, Kanagawa, Japan
Tel
0427788111
rinrib@med.kitasato-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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35443966/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35443966/
Number of participants that the trial has enrolled
782
Results
this study is the first to reveal that subjects with COVID 19 related acute respiratory failure during early mobility therapy in an ICU present a relatively high rate of non-serious adverse events despite the delayed initiation of mobilization in accordance with a recent study.10 Nevertheless, in these subjects, adverse events during early mobility therapy were not associated with poor clinical outcomes and higher in-hospital deaths.
Results date posted
| 2026 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who admitted in the ICU of Kitasato University Hospital for COVID 19 related acute respiratory failure treatment from October 1, 2020 to September 30, 2021. Subject characteristics, including biomarkers and severity scores, were collected on admission, whereas information regarding respiratory therapy and rehabilitation sessions was obtained during intensive care and clinical course. This study was performed in accordance with the Declaration of Helsinki and was approved by the ethics committee of Kitasato University.
Participant flow
Subjects were assessed by an ICU team consisting of physicians, nurses, and physiotherapists within 24 h of being admitted to the ICU to determine whether rehabilitation could be initiated. Early mobility therapy, particularly out-of-bed mobilization, was carried out based on specific medical recommendations. Early mobility therapy protocol consisted of monitoring of clinical conditions, evaluation of muscle strength by the Medical Research Council (MRC) scale, and prevention of disability by active limb exercises and out-of-bed exercise. The level of out-of-bed exercise was assessed with the ICU mobility scale and determined based on the subjects MRC scale. Each early mobility therapy session was implemented by ICU nurses and one of 4 physiotherapists with specialized knowledge about intensive care. During all early mobility therapy sessions, the following adverse events stated in the global consensus were recorded: worsening dyspnea, breathing frequency > 30 breaths/min, percutaneous oxygen saturation SpO2 < 93% on oxygen therapy, requirement of an FIO2 > 0.50 or PEEP > 10 cm H2O, respiratory distress, arterial hypertension or hypotension, bradycardia or tachycardia, intercurrent arrhythmia, or shock.
Adverse events
no events
Outcome measures
The 7-category ordinal scale consisted of the following categories: (1) not hospitalized and with resumption of normal activities; (2) not hospitalized but was unable to resume normal activities; (3) hospitalized but did not require supplemental oxygen; (4) hospitalized and required supplemental oxygen; (5) hospitalized and required nasal high-flow oxygen therapy, noninvasive ventilation, or both; (6) hospitalized and required extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and (7) death.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051988
