UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057259 |
|---|---|
| Receipt number | R000065454 |
| Scientific Title | Early bedside exercise training in hospitalized patients with COVID-19 pneumonia: a prospective, single-arm interventional study |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2025/03/11 16:34:31 |
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Basic information
Public title
Early bedside exercise training in hospitalized patients with COVID-19 pneumonia: a prospective, single-arm interventional study
Acronym
Early bedside exercise training in hospitalized patients with COVID-19 pneumonia: a prospective, single-arm interventional study
Scientific Title
Early bedside exercise training in hospitalized patients with COVID-19 pneumonia: a prospective, single-arm interventional study
Scientific Title:Acronym
Early bedside exercise training in hospitalized patients with COVID-19 pneumonia: a prospective, single-arm interventional study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study were to explore the impact of early pulmonary rehabilitation on isolated patients with COVID-19.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of changes in Borg score, SpO2, and HR between at enrollment and before discharge
Key secondary outcomes
Comparison of 1MSTST repetitions, CAT score, and HADS score between at enrollment and before discharge
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Bedside exercise training program included flexibility exercise, strength exercise, early mobilization, and breathing exercise in patients' own room in the infectious isolation ward
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
A diagnosis of COVID-19 pneumonia, hypoxemia in the degree of oxygen saturation measured by pulse oximetry (SpO2) less than 95%, and understanding the training program under infection control
Key exclusion criteria
Having the potentially significant hypoxemia on exercise, difficulty of exercise due to complications or disability, a cardiac disease that is stopped from exercise by a physician, diagnosis with dementia, and having visual or hearing impairment that prevents exercise training
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama, Kanagawa
TEL
045-701-9581
gda_kawasaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama, Kanagawa
TEL
045-701-9581
Homepage URL
gda_kawasaki@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
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
Kanagawa Cardiovascular and Respiratory Center
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama, Kanagawa
Tel
0457019581
gda_kawasaki@yahoo.co.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
| 2025 | Year | 03 | Month | 11 | 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
26
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065454
