UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035130 |
|---|---|
| Receipt number | 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 | 2023/07/13 13:03:39 |
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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
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL
+81-75-251-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL
+81-75-251-5506
Homepage URL
mhama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
Tel
075-251-5111
rinri@koto.kpu-m.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
| 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039853
| 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 |
