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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038836
Receipt No. 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

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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
Email 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
Email wwwhd422@yahoo.co.jp

Sponsor
Institute Hamamatsu University Schoolof Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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