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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036067
Receipt No. 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 2019/05/28

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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
Email 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
Email r0720086@gmail.com

Sponsor
Institute Handa City Handa Hospital

Department of Rehabilitation
Institute
Department

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
Email 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 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
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
2020 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
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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