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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015079
Receipt No. R000017543
Scientific Title Effects of the continuous intervention for physical activity on the habit of exercising and diabetic control in type 2 diabetics
Date of disclosure of the study information 2014/09/10
Last modified on 2020/05/03

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Basic information
Public title Effects of the continuous intervention for physical activity on the habit of exercising and diabetic control in type 2 diabetics
Acronym Effects of the continuous intervention for physical activity in type 2 diabetics
Scientific Title Effects of the continuous intervention for physical activity on the habit of exercising and diabetic control in type 2 diabetics
Scientific Title:Acronym Effects of the continuous intervention for physical activity in type 2 diabetics
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of the continuous intervention for physical activity on the habit of exercising and diabetic control in type 2 diabetics after diabetes educational programs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Acquisition of habitual exersing
2. Glycemic control (HbA1c)
Key secondary outcomes Other laboratory data and examination for motor ability

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 not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention for physical activity at every visit
Interventions/Control_2 Conventional treatment
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 Patients with type 2 diabetes mellitus who received exercise instructions according to diabetes educational programs (in or out patient)
Key exclusion criteria Patients who cannot visit to the hospital regularly
Patients with cognitive impairment
Patients with unstable complications obstructing exercise or walk
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Tamatani
Organization Kawashima Hospital
Division name Department of rehabilitation
Zip code 770-8548
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Email takahiro1208@mf.pikara.ne.jp

Public contact
Name of contact person
1st name Machiko
Middle name
Last name Komatsu
Organization Kawashima Hospital
Division name Department of diabetes mellitus
Zip code 770-8548
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Homepage URL
Email machikomatsu@r7.dion.ne.jp

Sponsor
Institute Kawashima Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawashima Hospital Ethics Review Committee
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
Tel 088-631-0110
Email sasaka@khg.or.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 川島病院(徳島県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 25
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 Completed
Date of protocol fixation
2014 Year 09 Month 02 Day
Date of IRB
2014 Year 09 Month 02 Day
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 03 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 07 Day
Last modified on
2020 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017543

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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