UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053916 |
|---|---|
| Receipt number | R000061541 |
| Scientific Title | Elucidation of metabolic response mechanisms in exercise matched to chronotype and time of execution. |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/20 18:56:54 |
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Basic information
Public title
Elucidation of metabolic response mechanisms in exercise matched to chronotype and time of execution.
Acronym
Elucidation of metabolic response mechanisms in exercise matched to chronotype and time of execution.
Scientific Title
Elucidation of metabolic response mechanisms in exercise matched to chronotype and time of execution.
Scientific Title:Acronym
Elucidation of metabolic response mechanisms in exercise matched to chronotype and time of execution.
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanisms of metabolic response in exercise matched to chronotype and time of execution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Substrate oxidation
Key secondary outcomes
Chronotype
Anaerobic Metabolic Threshold
Maximum VO2
Body temperature
Autonomic Activity
Rate of perceived exertion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Cardiopulmonary Exercise Test (9:00 AM)=>Washout Period: 1 week or longer=>Cardiopulmonary Exercise Test (7:00 PM)
Interventions/Control_2
Cardiopulmonary Exercise Test (7 p.m.) => washout period: at least 1 week=> Cardiopulmonary Exercise Test (9 a.m.)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Students enrolled at International University of Health and Welfare, Narita Campus
2. Students who are able to obtain written consent to participate in the research of their own free will.
3. Age at the time of consent: 18 years or older
4. Gender: Male
Key exclusion criteria
1. Consumption of alcohol or caffeine within 24 hours prior to the study
2. traveled abroad within 4 weeks prior to the study
3. have a sleep disorder
4. who worked night shift or shift work within one year prior to the study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | yuusuke |
| Middle name | |
| Last name | nishida |
Organization
International University of Health and Welfare
Division name
Physical Therapy, Narita University of Health Sciences
Zip code
286-8686
Address
4-3, Kouzu-no-mori, Narita-shi, Chiba
TEL
0476-20-7701
yuusuken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | yuuto |
| Middle name | |
| Last name | watabe |
Organization
International University of Health and Welfare Narita Hospital
Division name
Rehabilitation Department
Zip code
286-8520
Address
852 Hatagata, Narita-shi, Chiba
TEL
090-5585-5993
Homepage URL
23S1192@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Tokyo Akasaka District Ethics Review Committee
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.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
国際医療福祉大学成田キャンパス（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
