UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045708 |
|---|---|
| Receipt number | R000052168 |
| Scientific Title | Influence of emotional response to exercise on physical activity in type 2 diabetes patients |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/10/08 21:23:55 |
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Basic information
Public title
The effect of Diabetes educational program in hospitalization on the physical activity.
Acronym
Study of diabetes education program in hospitalization
Scientific Title
Influence of emotional response to exercise on physical activity in type 2 diabetes patients
Scientific Title:Acronym
Study of physical activity in type 2 diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetes patinets
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is clarify the effect of emotional response to exercise on physical activity in type 2 diabetes patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise instruction for 1week
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Type 2 diabetes patients
2.Patients who have given consent
Key exclusion criteria
1.Patients unable to exercise
2.Patients unable to walk
3.Patients with impaired cognitive function
4.Ptatients with lower amputation
5.Patients unable to give consent
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ishida |
| Middle name | |
| Last name | Takeki |
Organization
International University of Health and welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
0476-20-7701
takekii@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ishida |
| Middle name | |
| Last name | Takeki |
Organization
International University of Health and welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
0476-20-7701
Homepage URL
takekii@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and welfare
Address
4-3, Kozunomori, Narita City, Chiba
Tel
0476-20-7701
takekii@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | 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
| 2021 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052168
