UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038836 |
|---|---|
| Receipt number | R000044290 |
| Scientific Title | Survey of motor function in patients undergoing high-dose steroid therapy |
| Date of disclosure of the study information | 2019/12/12 |
| Last modified on | 2020/06/15 14:44:46 |
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Basic information
Public title
Survey of motor function in patients undergoing high-dose steroid therapy
Acronym
Survey of motor function in patients undergoing high-dose steroid therapy
Scientific Title
Survey of motor function in patients undergoing high-dose steroid therapy
Scientific Title:Acronym
Survey of motor function in patients undergoing high-dose steroid therapy
Region
| Japan |
Condition
Condition
collagen disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of exercise in patients undergoing high-dose glucocorticoid treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
Exercise
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consent to participate
Life independence
Motor functions that can be measured
Key exclusion criteria
Neurological problems
Cardiovascular problems
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | NAGASHIMA |
| Middle name | |
| Last name | MASAAKI |
Organization
Hamamatsu University Schoolof Medicine
Division name
Department of Rehabilitation
Zip code
431-3192
Address
Hamamatsu Higashi Handayama 1-20-1
TEL
053-435-2746
wwwhd422@yahoo.co.jp
Public contact
Name of contact person
| 1st name | NAGASHIMA |
| Middle name | |
| Last name | MASAAKI |
Organization
Hamamatsu University Schoolof Medicine
Division name
Department of Rehabilitation
Zip code
431-3192
Address
Hamamatsu Higashi Handayama 1-20-1
TEL
053-435-2746
Homepage URL
wwwhd422@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University Schoolof Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University Schoolof Medicine
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
Hamamatsu University Schoolof Medicine
Address
Department of Rehabilitation
Tel
053-435-2746
wwwhd422@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
| 2019 | Year | 12 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 10 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044290
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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