UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024469 |
|---|---|
| Receipt number | 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 | 2021/12/07 11:53:55 |
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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 | Shizuo |
| Middle name | |
| Last name | Sakamoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192 Japan
TEL
04-2947-4545
s.sakamoto@waseda.jp
Public contact
Name of contact person
| 1st name | Hyeon-Ki |
| Middle name | |
| Last name | Kim |
Organization
Waseda University
Division name
School of Advanced Science and Engineering
Zip code
162-8480
Address
TWIns 1F-C302, 2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo
TEL
03-5369-7318
Homepage URL
hk.kim@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
Waseda University
Address
1-104 Totsuka, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
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
38
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 | 10 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028157
