UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055396 |
|---|---|
| Receipt number | R000063307 |
| Scientific Title | Impact of physical fatigue from exercise on nighttime sleep |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2025/10/29 09:52:01 |
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Basic information
Public title
Impact of physical fatigue from exercise on nighttime sleep
Acronym
Impact of physical fatigue from exercise on nighttime sleep
Scientific Title
Impact of physical fatigue from exercise on nighttime sleep
Scientific Title:Acronym
Impact of physical fatigue from exercise on nighttime sleep
Region
| Japan |
Condition
Condition
Healthy male (19-39 years)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of physical fatigue induced by aerobic and resistance exercise on nighttime sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polysomnography (sleep architecture)
Fatigue level
Key secondary outcomes
Digital trail making peg test (cognitive function)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
control, moderate intensity aerobic exercise, moderate intensity resistance exercise, high intensity aerobic exercise, high intensity resistance exercise
Interventions/Control_2
control, moderate intensity aerobic exercise, high intensity aerobic exercise, moderate intensity resistance exercise, high intensity resistance exercise
Interventions/Control_3
control, high intensity aerobic exercise, high intensity resistance exercise, moderate intensity aerobic exercise, moderate intensity resistance exercise
Interventions/Control_4
high intensity aerobic exercise, high intensity resistance exercise, moderate intensity aerobic exercise, moderate intensity resistance exercise, control
Interventions/Control_5
high intensity resistance exercise, moderate intensity aerobic exercise, moderate intensity resistance exercise, control, high intensity aerobic exercise
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men aged 19 to 39
Individual without regular exercise habits
Individual not taking medications or health supplements aimed at improving fatigue levels or sleep quality
Individual without cardiovascular or metabolic diseases
Key exclusion criteria
Individual unable to perform 60 minutes of exercise
Individual without regular lifestyle habits
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL
029-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jaehee |
| Middle name | |
| Last name | Lee |
Organization
University of Tsukuba
Division name
Doctoral Program in Physical Education, Health and Sport Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL
029-853-2639
Homepage URL
s2230491@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Alinamin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
Tel
029-853-2571
tg-kenkyurinri@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（茨城県）/ University of Tsukuba (Ibaraki, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 03 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063307
