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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023911
Receipt No. R000027534
Scientific Title Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Date of disclosure of the study information 2016/09/02
Last modified on 2017/09/05

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Basic information
Public title Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Acronym Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Scientific Title Effects of lifestyle intervention with high-intensity interval training on metabolic syndrome: Randomized Controlled Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomoaki Matsuo
Organization National Institute of Occupational Safety and Health, Japan
Division name Occupational Epidemiology Research Group
Zip code
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
1st name
Middle name
Last name Rina So
Organization National Institute of Occupational Safety and Health, Japan
Division name Research Center for Overwork-Related Disorders
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2016 Year 08 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027534

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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