UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of high intensity interval training on insulin sensitivity and body composition using arm&leg ergometer
Title of the study (Brief title)	HIT study
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of High intesity interval training on fitness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximal oxygen uptake
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	High intensity interval training using arm and leg ergometers
Interventions/Control_2	High intensity interval training using leg ergometer
Interventions/Control_3	Moderate intensity endurance training
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	no serious commobidity able to perform high intesity interval training
Key exclusion criteria	pregnancy already physically very active
Target sample size	40

Research contact person
Name of lead principal investigator	azuma koichiro
Organization	School of Medicine, Keio University
Division name	Institute for Integrated Sports Medicine
Address	35 shinanomachi shinjuku tokyo160-8582
TEL	03-3353-1211
Email

Public contact
Name of contact person
Organization	School of Medicine, Keio University
Division name	Institute for Integrated Sports Medicine
Address
TEL	03-3353-1211
Homepage URL
Email

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio University
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

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 09 Day
Anticipated trial start date	2011 Year 09 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 24 Day
Last modified on	2018 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008938