UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050994 |
|---|---|
| Receipt number | R000058132 |
| Scientific Title | Effects of Participatory Exercise Education Interventions in Diabetes Population Education on Exercise Self-Efficacy in Patients |
| Date of disclosure of the study information | 2023/05/06 |
| Last modified on | 2023/05/06 20:10:56 |
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Basic information
Public title
Effects of Participatory Exercise Education Interventions in Diabetes Population Education on Exercise Self-Efficacy in Patients
Acronym
Effects of Educational Interventions in Diabetic Patients on Exercise Self-Efficacy
Scientific Title
Effects of Participatory Exercise Education Interventions in Diabetes Population Education on Exercise Self-Efficacy in Patients
Scientific Title:Acronym
Effects of Educational Interventions in Diabetic Patients on Exercise Self-Efficacy
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in exercise self-efficacy in diabetes group education in order to verify the effects of interventions that promote behavior change through diabetes patient education interventions and from the perspective of continuing exercise, and to verify whether there are differences in changes in educational interventions of different types of educational interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in exercise self-efficacy before and after diabetes group education intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the lecture group, an epidemiological overview of type 2 diabetes, the effects of exercise therapy, and exercise implementation methods were given to subjects in a lecture style of about 30 minutes.
Interventions/Control_2
In the participatory group, stretching, strength training, and aerobic exercise were performed for about 30 minutes in addition to the content of the lecture-type classroom.
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
| 30 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who have received consent to participate in diabetes classes, have not developed serious complications, and are judged by a doctor to be able to exercise safely
Key exclusion criteria
1.Type 1 diabetics
2.Excludes data from the second and subsequent times for patients who participated more than once
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Sato |
Organization
TMG Asaka Medical Center
Division name
Department of Rehabilitation
Zip code
351-0023
Address
Saitama-ken Asaka-shi Mizonuma 1340-1
TEL
0570-07-2055
r_sato3@tmg.or.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Sato |
Organization
TMG Asaka Medical Center
Division name
Department of Rehabilitation
Zip code
351-0023
Address
Saitama-ken Asaka-shi Mizonuma 1340-1
TEL
0570-07-2055
Homepage URL
r_sato3@tmg.or.jp
Sponsor or person
Institute
TMG Asaka Medical Center
Department of Rehabilitation
Sato Ryuta
Institute
Department
Personal name
Funding Source
Organization
TMG Asaka Medical Center
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
TMG Asaka Medical Center Ethics Committee4
Address
Saitama-ken Asaka-shi Mizonuma 1340-1
Tel
0570-07-2055
r_sato3@tmg.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058132
