UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040428 |
|---|---|
| Receipt number | R000046137 |
| Scientific Title | Exercise improves the quality of slow wave sleep by increasing slow wave stability |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/05/18 11:37:26 |
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Basic information
Public title
Exercise improves the quality of slow wave sleep by increasing slow wave stability
Acronym
Exercise improves the quality of slow wave sleep
Scientific Title
Exercise improves the quality of slow wave sleep by increasing slow wave stability
Scientific Title:Acronym
Exercise improves the quality of slow wave sleep
Region
| Japan |
Condition
Condition
Healthy male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study evaluated the effects of a single bout of vigorous exercise in young healthy males on the metabolic state of subsequent sleep and on its quality. We found a lasting effect of exercise on the metabolic state and opposite effects on subjective and objective measures of sleep quality, respectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep and energy metabolism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A single bout of exercise
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
20 to 30 yr of age, body mass index of 18.0 to 29.9 (kg/m2), a regular sleep / wake pattern and had no engagement in regular exercise more than twice a week.
Key exclusion criteria
self-reported sleep problems (Pittsburgh Sleep Quality Index score > 5); shiftwork or transmeridian travel within 1 month before the study; smoking; excessive alcohol intake (>30 g alcohol / day); ongoing medication for cardiovascular disease, diabetes, hypercholesterolaemia, hyperglycaemia, or hyperlipidaemia; and the use of medications affecting sleep or metabolism.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | INSUNG |
| Middle name | |
| Last name | PARK |
Organization
IIIS
Division name
Human physiology
Zip code
3058550
Address
1-2 Kasuga, Tsukuba, Ibaraki
TEL
0298591290
park.insung.ge@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | INSUNG |
| Middle name | |
| Last name | PARK |
Organization
University of Tsukuba
Division name
IIIS
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba, Ibaraki
TEL
0298591858
Homepage URL
park.insung.ge@u.tsukuba.ac.jp
Sponsor or person
Institute
IIIS
Institute
Department
Personal name
Funding Source
Organization
IIIS
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
IIIS
Address
1-2 Kasuga, Tsukuba, Ibaraki
Tel
0298591858
park.insung.ge@u.tsukub.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
9
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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046137
| 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 |
