UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of physical exercise on sleep structure and physiological functions during nocturnal sleep
Title of the study (Brief title)	The effect of physical exercise on sleep
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is generally believed that physical exercise can improve sleep quality. This may be due to the effects of exercise on sleep structure produced by physiological changes in body temperature, autonomic nervous system, metabolic function, and endocrine function during sleep. In this study, we focused on the amount of exercise and used an exercise protocol to examine the effects of physical exercise on sleep structure, changes in core body temperature and other physiological parameters before bedtime and during sleep, correlations of these parameters with sleep, and subjective evaluations from before and after sleep.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep structure (Nocturnal sleep period after physical exercise in exercise condition and same period in baseline condition)
Key secondary outcomes	Body temperature, Subjective parameters, sleep log, Metabolic function, Cognitive functions,

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	Behavior,custom
Interventions/Control_1	Exercise condition: Each participant has a workout on a bicycle ergometer for 4 times throughout the day before 4 times cognitive task sessions.
Interventions/Control_2	Baseline condition: Each participant is prohibited from exercising throughout the day and performs 4 times cognitive task sessions.
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	40 years-old >
Gender	Male
Key inclusion criteria	1. Participants are fourteen healthy male volunteers 2. A person who have regular sleep habits and habitually exercised less than twice a week. 3. The details of the study and explanation of its aims in writing are explained to the participants and their written informed consent are obtained.
Key exclusion criteria	1. A person who have a neurological, psychiatric disorder, or sleep disorders. 2. A person who have a history of psychoactive drug use, antihistamines, other hypnotic effect drugs use. 3. A person who takes in caffeine, nicotine, and alcohol for 1 week prior to the experiment. 4. A person who is shift-worker, or who traveled the area of time difference 1 month before the experiment.
Target sample size	20

Research contact person
Name of lead principal investigator	Sunao Uchida
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	Mikajima 2-579-19, Tokorozawa, Saitama
TEL	04-2947-6809
Email	sunao@waseda.jp

Public contact
Name of contact person	Sayaka Aritake
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	Mikajima 2-579-19, Tokorozawa, Saitama
TEL	04-2947-6809
Homepage URL
Email	saayaca@gmail.com

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Research Grant of KAO Corporation The JSPS KAKENHI (Grant-in-aid for Scientific Research) (Grant Number 15K18980)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cross over study

Management information
Registered date	2017 Year 02 Month 26 Day
Last modified on	2017 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030217