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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031263
Receipt No. 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 2020/02/14

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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
Email 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
Email dmnaika@tokyo-med.ac.jp

Sponsor
Institute Hachioji Medical Center of Tokyo Medical University
Department of Diabetology,Endocrinology and Metabolism
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 13 Day
Last modified on
2020 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035694

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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