UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062967 |
|---|---|
| Receipt number | R000072087 |
| Scientific Title | A Prospective Pilot Study on the Continuation of Independent Home Practice in a Diabetes Education Program |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 17:32:47 |
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Basic information
Public title
A Prospective Pilot Study on the Continuation of Independent Home Practice in a Diabetes Education Program
Acronym
A Study on Independent Practice in Diabetes Education Classes
Scientific Title
A Prospective Pilot Study on the Continuation of Independent Home Practice in a Diabetes Education Program
Scientific Title:Acronym
A Study on Independent Practice in Diabetes Education Classes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct physical function assessments and provide exercise guidance to patients who have participated in our diabetes education program, and then evaluate their exercise adherence during the period leading up to the next session. The purpose of this study is to assess whether our hospitals diabetes education program contributes to patients ability to maintain a regular exercise routine on their own.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise Retention Rate
Key secondary outcomes
Locomo 25, Exercise Participation Status, Questionnaire Survey, Re-evaluation Rate, Background Factors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physical Function Assessment Exercise Instruction Survey
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals currently receiving outpatient care at the Endocrinology and Metabolism Clinic
Individuals with diabetes, prediabetes, or obesity, or those who wish to participate in a diabetes education class to improve their lifestyle habits
Individuals planning to participate in the diabetes education class to be held in September 2026
Key exclusion criteria
Individuals with medical conditions for which exercise is contraindicated
Individuals for whom a safe physical function assessment cannot be conducted, such as immediately following a serious cardiovascular event
Individuals for whom it is difficult to conduct the assessment due to poor physical condition on the day of the assessment
Individuals deemed unable to complete the questionnaire or continue participating in the study
Individuals deemed unsuitable by their attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | tashiro |
| Middle name | |
| Last name | aina |
Organization
Shimane University Hospital
Division name
Rehabilitation Department
Zip code
693-0021
Address
89-1 Shioya-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2457
aityan2001@gmail.com
Public contact
Name of contact person
| 1st name | tashiro |
| Middle name | |
| Last name | aina |
Organization
Shimane University Hospital
Division name
Rehabilitation Department
Zip code
693-0021
Address
89-1 Shioya-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2457
Homepage URL
aityan2001@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
tashiroaina
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital
Address
89-1 Shioya-cho, Izumo City, Shimane Prefecture
Tel
0853-20-2457
aityan2001@gmail.com
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
| 2026 | Year | 09 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072087
