UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of toe resistance training in patients with type 2 diabetes
Title of the study (Brief title)	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	Hiroaki Kataoka
Organization	KKR Takamatsu Hospital
Division name	Rehabilitation center
Address	4-18, Tenjinmae, Takamatsu, Kagawa, Japan
TEL	087-861-3261
Email	h.kataoka59@gmail.com

Public contact
Name of contact person	Hiroaki Kataoka
Organization	KKR Takamatsu Hospital
Division name	Rehabilitation center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://ousar.lib.okayama-u.ac.jp/ja/journal/amo/72/1/article/55657
Results
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