UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023911 |
|---|---|
| Receipt number | 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 08:53:15 |
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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)
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
sorina@h.jniosh.johas.go.jp
Sponsor or person
Institute
National Institute of Occupational Safety and Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
