UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Title of the study (Brief title)	Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Region	Japan

Condition
Condition	Metabolic syndrome
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of intervention program consisting of a high-intensity aerobic interval exercise and a caloric restriction on cardiorespiratory capacity and metabolic syndrome components.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiorespiratory capacity
Key secondary outcomes	Metabolic syndrome components Body fat Stress components

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	1.Non-intervention 2.High-intensity interval aerobic training (3 times/week, 8 weeks) 3.Low-calorie diet intervention (1 sessions/week, 4 weeks) 4.Non-intervention
Interventions/Control_2	1.Non-intervention 2.Low-calorie diet intervention (1 sessions/week, 4 weeks) 3.High-intensity interval aerobic training (3 times/week, 8 weeks) 4.High-intensity interval aerobic training (1 time/week, 8 weeks)
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Metabolic syndrome or Pre-metabolic syndrome
Key exclusion criteria	Participation in regular sports activities and weight-loss intervention for the past year
Target sample size	40

Research contact person
Name of lead principal investigator	Tomoaki Matsuo
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Occupational Epidemiology Research Group
Address	6-21-1, Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL	044-865-6111(8286)
Email	matsuo@h.jniosh.johas.go.jp

Public contact
Name of contact person	Rina So
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Research Center for Overwork-Related Disorders
Address	6-21-1, Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL	044-865-6111(8409)
Homepage URL
Email	sorina@h.jniosh.johas.go.jp

Sponsor
Institute	National Institute of Occupational Safety and Health, Japan
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	医療法人社団美心会黒沢病院（Kurosawa Hospital）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 02 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2017 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027534