UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026312
Receipt number R000030217
Scientific Title The effect of physical exercise on sleep structure and physiological functions during nocturnal sleep
Date of disclosure of the study information 2017/02/27
Last modified on 2017/02/26 15:49:19

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Basic information

Public title

The effect of physical exercise on sleep structure and physiological functions during nocturnal sleep

Acronym

The effect of physical exercise on sleep

Scientific Title

The effect of physical exercise on sleep structure and physiological functions during nocturnal sleep

Scientific Title:Acronym

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

1st name
Middle name
Last name Sunao Uchida

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

Mikajima 2-579-19, Tokorozawa, Saitama

TEL

04-2947-6809

Email

sunao@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sayaka Aritake

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

Mikajima 2-579-19, Tokorozawa, Saitama

TEL

04-2947-6809

Homepage URL


Email

saayaca@gmail.com


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2013 Year 11 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name