UMIN-CTR Clinical Trial

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
Email	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
Email	park.insung.ge@u.tsukuba.ac.jp

Sponsor
Institute	IIIS
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046137