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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011352
Receipt No. R000013302
Scientific Title An efficient cycling exercise protocol to improve metabolic syndrome components
Date of disclosure of the study information 2013/08/05
Last modified on 2014/07/02

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Basic information
Public title An efficient cycling exercise protocol to improve metabolic syndrome components
Acronym An efficient cycling exercise protocol to improve metabolic syndrome components
Scientific Title An efficient cycling exercise protocol to improve metabolic syndrome components
Scientific Title:Acronym An efficient cycling exercise protocol to improve metabolic syndrome components
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 an 8-week high-intensity aerobic interval exercise and a 4-week 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 Maximal Oxygen Consumption
Key secondary outcomes Metabolic syndrome components

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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 High-intensity interval aerobic training (13 min, 3 times/week, 8 weeks)
Caloric restriction (-500 kcal/day, 4 weeks)
Total 12 weeks
Interventions/Control_2 Moderate-intensity continuous aerobic training (40 min, 3 times/week, 8 weeks)
Caloric restriction (-500 kcal/day, 4 weeks)
Total 12 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
64 years-old >
Gender Male
Key inclusion criteria Body mass index >=25 kg/m2, <35 kg/m2 and abdominal circumference >=85 cm. We will give priority to a subject who satisfied at least one of the following three metabolic syndrome components (1. triglyceride >=150 mg/dl and/or high-density lipoprotein cholesterol <40 mg/dl; 2. SBP >=130 mmHg and/or DBP >=85 mmHg; or 3. fasting plasma glucose >=110 mg/dl).
Key exclusion criteria Participation in regular sports activities and weight-loss intervention for the past year
Target sample size 26

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 Hazard Evaluation and Epidemiology Research Group
Zip code
Address 6-21-1, Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL 044-865-6111-8286
Email matsuo@h.jniosh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Matsuo
Organization National Institute of Occupational Safety and Health, Japan
Division name Hazard Evaluation and Epidemiology Research Group
Zip code
Address 6-21-1, Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL 044-865-6111-8286
Homepage URL
Email matsuo@h.jniosh.go.jp

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

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 05 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
2013 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 02 Day
Last modified on
2014 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013302

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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