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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027711
Receipt No. R000031744
Scientific Title Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Date of disclosure of the study information 2017/06/09
Last modified on 2019/08/30

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Basic information
Public title Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Acronym Exercise and arterial functions in obesity
Scientific Title Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Scientific Title:Acronym Exercise and arterial functions in obesity
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes [Before and after the 12-week intervention]
- Arterial functions (central hemodynamics)
Key secondary outcomes [Before and after the 12-week intervention]
- Insulin sensitivity
- Glucose tolerance
- Amino acids metabolism
- Intramyocellular lipids
- Extramyocellular lipids
- Visceral fat area
- Subcutaneous fat area
- Body mass/composition
- Bone strength
- Circulating factors (e.g., cytokines)
- Male sexual function
- Peak oxygen uptake
- Cognitive function
- Sedentary behavior
- Urinary biomarkers

[Baseline and week 11-12]
- Physical activity
- Sleep habits

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: aerobic exercise training (moderate intensity, 40-60 min per session, 3 sessions per week, 12 weeks)
Interventions/Control_2
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 BMI range: 25.0-34.9 kg/m2
Key exclusion criteria history of heart disease
history of stroke
Participation in an exercise program in the past year
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Maeda
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-8859
Email maeda@taiiku.tsukuba.ac.jp

Public contact
Name of contact person
1st name Kanae
Middle name
Last name Myoenzono
Organization University of Tsukuba
Division name Doctoral Program in Sports Medicine
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-5990
Homepage URL
Email s1730400@s.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee university of tsukuba
Address Tennodai, 1-1-1, Tsukuba, Ibaraki
Tel 029-853-2571
Email hitorinnri@un.tsukuba.ac.jp

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 筑波大学総合研究棟D

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 09 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 Main results already published
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
2017 Year 05 Month 29 Day
Anticipated trial start date
2017 Year 06 Month 10 Day
Last follow-up date
2017 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031744

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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