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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035130
Receipt No. R000039853
Scientific Title Multicenter randomized open-rebelled comparison test of radio exercise for patients with diabetes mellitus
Date of disclosure of the study information 2018/12/04
Last modified on 2019/01/19

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Basic information
Public title Multicenter randomized open-rebelled comparison test of radio exercise for patients with diabetes mellitus
Acronym The effect of radio exercise on patients with diabetes mellitus
Scientific Title Multicenter randomized open-rebelled comparison test of radio exercise for patients with diabetes mellitus
Scientific Title:Acronym The effect of radio exercise on patients with diabetes mellitus
Region
Japan

Condition
Condition Patients with diabetes
Classification by specialty
Endocrinology and Metabolism Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the Efficacy for Radio Exercise in hospitalized patients with diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of SMI evaluated by bioinpedance analysis between Radio exercise group and conventional exercise therapy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Control
Instructing a 30 minutes walking as the conventional exercise therapy.
Interventions/Control_2 Intervention
Instructing the radio exercise in addition to the conventional exercise therapy.
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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Diagnosed diabetes.
Obtained informed conscent.
Key exclusion criteria 1: ketonuria, serum more than 2.0mg/dl, or receiving hemodialysis
2: Severe diabetic neuropathy, or fresh hemorrhage in the eye ground caused by proliferative retinopathy
3: Severe liver disease, or endocrinology disease
4: Low motion durable capacity of a patient suffering from cardio pulmonary disease, cerebrovascular disease, or muscle skeletal disease
5: Refusal or lacks capacity to give informed consent to participate in the trial
Target sample size 74

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masahide Hamaguchi
Organization Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5506
Homepage URL
Email mhama@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2018 Year 12 Month 04 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 04 Day
Last modified on
2019 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039853

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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