UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042214 |
|---|---|
| Receipt number | R000048185 |
| Scientific Title | Relationships between physical activity during hospitalization and physical capacity after discharge from hospital in patients with COVID-19: a prospective observational study |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2023/04/25 14:44:44 |
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Basic information
Public title
Relationships between physical activity during hospitalization and physical capacity after discharge from hospital in patients with COVID-19: a prospective observational study
Acronym
Relationships between physical activity and physical capacity in patients with COVID-19
Scientific Title
Relationships between physical activity during hospitalization and physical capacity after discharge from hospital in patients with COVID-19: a prospective observational study
Scientific Title:Acronym
Relationships between physical activity and physical capacity in patients with COVID-19
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the relationships between physical activity during hospitalization and physical capacity after discharge from hospital in patients with COVID-19.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity, 6-minute walking test
Key secondary outcomes
Subjective symptoms, SpO2, Modified British Medical Research Council, Handgrip strength, Gait speed, 5 times sit to stand test, Sit to stand test
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
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COVID-19
Room air SpO2 > 93%
Walking alone
Exercise tolerance > 20 mins
Participants who understood the study purposes
Key exclusion criteria
Heart disease
Pulmonary disease
Lower extremity fracture
Body weight > 250kg
Acute disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sumiya |
Organization
Wakayama Medical University Kihoku Hospital
Division name
Department of Rehabilitation
Zip code
649-7113
Address
219, Myoji, Katusragi-cho, Ito-gun, Wakayama
TEL
0736-22-0066
t-sumiya@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Minetama |
Organization
Wakayama Medical University Kihoku Hospital
Division name
Department of Rehabilitation
Zip code
649-7113
Address
219, Myoji, Katusragi-cho, Ito-gun, Wakayama
TEL
0736-22-0066
Homepage URL
masakazumasakazu910@hotmail.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Institutional Review Board at Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2020 | Year | 10 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Physical activity is measured using activity monitor during hospitalization.
Subjective symptoms and physical capacity are assessed at discharge and a month after discharge.
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
