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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024469
Receipt No. R000028157
Scientific Title Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Date of disclosure of the study information 2016/10/20
Last modified on 2019/02/12

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Basic information
Public title Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Acronym Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Scientific Title Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Scientific Title:Acronym Effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Region
Japan

Condition
Condition obesity
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study was to compare the effects of endurance exercise training performed in the morning and evening on metabolism related indicators and blood lipids.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following measures would be conducted before and after 12 weeks of intervention.
1) metabolite and hormone
Key secondary outcomes 2) substrate metabolism
3) body composition
4) clock-gene

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The exercise morning group (0800 - 1100 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 12 weeks.
Interventions/Control_2 The exercise evening group (1700 - 2000 h) are asked to do moderate endurance exercise for a 60 min/session 3 d per week for 12 weeks.
Interventions/Control_3 Control group are asked to maintain their usual lifestyle during the same period as intervention group.
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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age between 20-79 years
2) Gives informed consent, agrees to be randomly assigned
Key exclusion criteria 1) Patients with a history of cardiovascular disease
2) Physically active lifestyle
3) Intake of lipid and/or glucose lowering medication in the previous 3 months
4) Smoking habit
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuo Sakamoto
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama,359-1192 Japan
TEL 04-2947-4545
Email s.sakamoto@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hyeon-Ki Kim
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama,359-1192 Japan
TEL 04-2947-4545
Homepage URL
Email h.kim5@kurenai.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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
2016 Year 10 Month 20 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
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 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
2016 Year 10 Month 18 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028157

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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