UMIN-CTR Clinical Trial

Basic information
Public title	An explorative study about the effects of exercise on sleep, physical function and quality of life in elderly people
Acronym	Effects of exercise on sleep, physical function and quality of life in elderly people
Scientific Title	An explorative study about the effects of exercise on sleep, physical function and quality of life in elderly people
Scientific Title:Acronym	Effects of exercise on sleep, physical function and quality of life in elderly people
Region	Japan

Condition
Condition	Elderly people
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of mild exercise after morning wake-up on sleep, physical function/ability and QOL (quality of life) in elderly people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep status Physical function/ability QOL
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	About 15 minutes of mild exercise after morning wake-up for four weeks
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	65 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Aged 65 to 90 years (2) Able to get out of bed during daytime hours, if institutionalized (3) Able to walk with a cane and/or an orthosis (FIM-scored 6 or over on walk/wheelchair item) (4) Approved to participate in this study by the facility director, if institutionalized or facility attending (5) Who gave their written informed consent for participation in this study
Key exclusion criteria	(1) Scored less than 24 on the Mini-Mental Sensitive Estimate (2) Not able to fully understand the requested exercise routine (3) Not approved to exercise by the attending physician (4) Not approved to participate in this study by the lead principal investigator and/or other researcher in charge
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Shinkoda
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8553
Address	2-3, Kasumi 1-chome, Minami-ku, Hiroshima-shi, Hiroshima-ken
TEL	082-257-5415
Email	shinkoda@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Takahashi
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8553
Address	2-3, Kasumi 1-chome, Minami-ku, Hiroshima-shi, Hiroshima-ken
TEL	082-257-5415
Homepage URL
Email	mako2@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Hiroshima University Certified Review Board
Address	2-3, Kasumi 1-chome, Minami-ku, Hiroshima-shi, Hiroshima-ken
Tel	082-257-1576
Email	kasumi-kenkyu@office.hiroshima-u.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	2018 Year 02 Month 18 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	Completed
Date of protocol fixation	2017 Year 11 Month 15 Day
Date of IRB	2017 Year 11 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2022 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	2018 Year 02 Month 18 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035801