UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031356 |
|---|---|
| Receipt number | 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 | 2022/03/04 14:36:56 |
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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
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
mako2@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035801
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
