UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015079 |
|---|---|
| Receipt number | 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 12:49:10 |
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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
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
machikomatsu@r7.dion.ne.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017543
