UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031263 |
|---|---|
| Receipt number | R000035694 |
| Scientific Title | Study of Exercise education in clinics by Mediwalk and physical activity management tool |
| Date of disclosure of the study information | 2018/02/13 |
| Last modified on | 2022/08/17 10:06:35 |
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Basic information
Public title
Study of Exercise education in clinics by Mediwalk and physical activity management tool
Acronym
Study of Exercise education in clinics by Mediwalk and physical activity management tool(Physical Act Study)
Scientific Title
Study of Exercise education in clinics by Mediwalk and physical activity management tool
Scientific Title:Acronym
Study of Exercise education in clinics by Mediwalk and physical activity management tool(Physical Act Study)
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effective methods of exercise education for outpatients in clinics using Walking Intensity Monitor(Mediwalk)and physical activity management tool
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity(Mets/Day)and the change from baseline at 6 months.
Key secondary outcomes
Body composition
Muscle function
HbA1c
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Exercise education using Mediwalk with physical activity management tool in 6 months
Interventions/Control_2
Using Walking Intensity Monitor(Mediwalk)in 6 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatients with diabetes
over 20years old
who give written informed consent to participate in the study.
Key exclusion criteria
Persons who have significant limitations in their walking and activities of daily of living.
Persons who are judged as unsuitable for this study by the primary doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Ohno |
Organization
Hachioji Medical Center of Tokyo Medical University
Division name
Department of Diabetology,Endocrinology and Metabolism
Zip code
193-0998
Address
1163 Tate-machi Hachioji-city Tokyo JAPAN
TEL
042-665-5611
dmnaika@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Awane |
Organization
Hachioji Medical Center of Tokyo Medical University
Division name
Departmento of Diabetology,Endocrinology and Metabolism
Zip code
193-0998
Address
1163 Tate-machi Hachioji-city Tokyo JAPAN
TEL
042-665-5611
Homepage URL
dmnaika@tokyo-med.ac.jp
Sponsor or person
Institute
Hachioji Medical Center of Tokyo Medical University
Department of Diabetology,Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
TERUMO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
MYOUJIN TOU CLINIC
Hachioji Diabetes Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1 Nisisinjyuku Sinjyuku-ku Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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
・医療法人社団せいこう会みょうじん糖クリニック(MYOUJIN TOU CLINIC)
・八王子糖尿病内科クリニック(Hachioji Diabetes Clinic)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
100
Results
Unpublished
Results date posted
| 2022 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035694
| Research Plan | |
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| 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 |
