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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026488
Receipt No. R000030427
Scientific Title Effect of toe resistance training in patients with type 2 diabetes
Date of disclosure of the study information 2017/03/10
Last modified on 2018/02/26

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Basic information
Public title Effect of toe resistance training in patients with type 2 diabetes
Acronym Effect of toe resistance training in patients with type 2 diabetes
Scientific Title Effect of toe resistance training in patients with type 2 diabetes
Scientific Title:Acronym Effect of toe resistance training in patients with type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the effectiveness of toe resistance training in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in toe pinch force
Key secondary outcomes Change in toe muscle quality
Change in glycemic control
Change in motor function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Toe resistance training
Aerobic exercise
Interventions/Control_2 Aerobic exercise
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
80 years-old >
Gender Male and Female
Key inclusion criteria Inpatients with type 2 diabetes give written informed consent to participate in the study.
Key exclusion criteria 1. Patients having acute metabolic disorders.
2. Patients with acute or chronic bone and joint disease, and cerebral vascular disease.
3. Patients having foot/toe deformity, or muscle atrophy and edema of the foot.
4. Patients whose daily activities are highly restricted.
5. Patients hospitalized for surgery.
6. Patients who seem inappropriate for this study by investigations.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kataoka
Organization KKR Takamatsu Hospital
Division name Rehabilitation center
Zip code
Address 4-18, Tenjinmae, Takamatsu, Kagawa, Japan
TEL 087-861-3261
Email h.kataoka59@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kataoka
Organization KKR Takamatsu Hospital
Division name Rehabilitation center
Zip code
Address 4-18, Tenjinmae, Takamatsu, Kagawa, Japan
TEL 087-861-3261
Homepage URL
Email h.kataoka59@gmail.com

Sponsor
Institute KKR Takamatsu Hospital
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
Address
Tel
Email

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 KKR高松病院(香川県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://ousar.lib.okayama-u.ac.jp/ja/journal/amo/72/1/article/55657
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 Completed
Date of protocol fixation
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2018 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030427

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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