UMIN-CTR Clinical Trial

Basic information
Public title	The examination of the effect for the short time acceleration training on lifestyle-related disease
Acronym	The examination of the effect for the short time acceleration training on lifestyle-related disease
Scientific Title	The examination of the effect for the short time acceleration training on lifestyle-related disease
Scientific Title:Acronym	The examination of the effect for the short time acceleration training on lifestyle-related disease
Region	Japan

Condition
Condition	lifestyle-related diseases
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of an effect on lifestyle-related disease of the short acceleration training and body function and the improvement effect
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After six months, We evaluate a lipid-related item, body function.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The training using the acceleration training machine of 5 min/time, 4 times a week (any day)
Interventions/Control_2	Control
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The persons with lifestyle-related disease. One of the following standards was reported by a clinical survey and a medical examination BMI above 25 kg/m2 HDL-cho under 40 mg/dl LDL-cho above 120 mg/dl TG above 150 mg/dl FPG above 100 mg/dl HbA1c above 5.6 persent
Key exclusion criteria	The patient who has retinal, PDR/PPDR, and the person during the pregnancy and pregnancy applicants
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akihisa Middle name Last name Imagawa
Organization	Osaka Medical College
Division name	Internal medicine I
Zip code	569-8686
Address	2-7, Dagaku-chou, Takatsuki city, Osaka
TEL	072-683-1221
Email	in1337@osaka-med.ac.jp

Public contact
Name of contact person	1st name Reiko Middle name Last name Fujisawa
Organization	Osaka Medical College
Division name	Internal medicine
Zip code	569-8686
Address	2-7, Dagaku-chou, Takatsuki city, Osaka
TEL	072-683-1221
Homepage URL
Email	in1337@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Internal medicine
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	Osaka Medical college
Address	2-7, Dagaku-chou, Takatsuki city, Osaka
Tel	072-683-1221
Email	rinri@art.osaka-med.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	2015 Year 11 Month 11 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	23
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	2015 Year 07 Month 10 Day
Date of IRB	2015 Year 09 Month 07 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2018 Year 09 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 11 Day
Last modified on	2019 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022814