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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031356
Receipt No. R000035801
Scientific Title An explorative study about the effects of exercise on sleep, physical function and quality of life in elderly people
Date of disclosure of the study information 2018/02/18
Last modified on 2020/03/07

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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 No longer recruiting
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
2021 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
2020 Year 03 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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