UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036067 |
|---|---|
| Receipt number | R000041085 |
| Scientific Title | The effects of exercise support using a small terminal on patient with diabetes mellitus weight loss in diabetes education hospitalization |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/09/03 18:46:07 |
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Basic information
Public title
The effects of exercise support using a small terminal on patient with diabetes mellitus weight loss in diabetes education hospitalization
Acronym
The effects of exercise support using a small terminal on weight loss
Scientific Title
The effects of exercise support using a small terminal on patient with diabetes mellitus weight loss in diabetes education hospitalization
Scientific Title:Acronym
The effects of exercise support using a small terminal on weight loss
Region
| Japan |
Condition
Condition
Type 2 diabetes meliitus with obesity
Classification by specialty
| Clinical immunology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifies the effect on weight loss and exercise habit acquisition rate to intervention using a small terminal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, Waist circumference,Laboratory data (Hemoglobin A1c,Fasting plasma glucose, HDL-cholesterol, LDL-cholesterol, Triglycerides, Urine-C peptide immunore activity, Homeostasis model assessment of insulin resistance)
Measure at the start and hospital discharge
Key secondary outcomes
Number of steps per day, Stage of the transtheoretical model of behavior change, Sense of coherence scale score
Measure at the start and hospital discharg
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
Intervention group
Earobic exercise
1.Cycle ergometer thirty minutes
2.Walking one hour
For 8 to 10 days
Combined use of instruction are perfomed by oral and small terminal
Interventions/Control_2
Control group
Earobic exercise
1.Cycle ergometer thirty minutes
2.Walking one hour
For 8 to 10 days
Instruction are perfomed by oral
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes meliitus with obesity
Key exclusion criteria
Exercise is contraindicated
Functional status ADL non independent
Mild cognitive impairment and major neurocognitive disorder
Insulin dependent
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Ishiguro |
Organization
Handa City Handa Hospital
Division name
Department of Rehabilitation
Zip code
475-8599
Address
2nd 29th Toyocho, Handa City, Aichi Prefecture
TEL
0569-22-9881
r0720086@gmail.com
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Ishiguro |
Organization
Handa City Handa Hospital
Division name
Department of Rehabilitation
Zip code
475-8599
Address
2nd 29th Toyocho, Handa City, Aichi Prefecture
TEL
0569-22-9881
Homepage URL
r0720086@gmail.com
Sponsor or person
Institute
Handa City Handa Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Handa City Handa Hospital
Address
2nd 29th Toyocho, Handa City, Aichi Prefecture
Tel
0569-22-9881
r0720086@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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2019 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041085
