UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053940 |
|---|---|
| Receipt number | R000061277 |
| Scientific Title | Effects of modified sleep habit on locomotive function in older adults: randomized controlled trial |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2025/05/01 12:45:06 |
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Basic information
Public title
Effects of modified sleep habit on locomotive function in older adults
Acronym
Clinical trial for locomotive funtion in older adults
Scientific Title
Effects of modified sleep habit on locomotive function in older adults: randomized controlled trial
Scientific Title:Acronym
Clinical trial for locomotive funtion in older adults
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of lifestyle modification, including sleep habits, on locomotive function in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Locomotive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Multi-component exercises including squats.(3 months)
Consumption of a variety of foods including protein foods.(3 months)
Watching sleep education videos and Performing sleep-promoting behaviors.(3 months)
Interventions/Control_2
Multi-component exercises including squats.(3 months)
Watching sleep education videos and Performing sleep-promoting behaviors.(3 months)
Interventions/Control_3
Multi-component exercises including squats.(3 months)
Consumption of a variety of foods including protein foods.(3 months)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who are at least 60 years of age at the time consent is obtained.
Persons who can provide written consent to participate in this study.
Persons who have a smart phone.
Key exclusion criteria
Persons who already have a strength training habit. Specifically, those who have performed strength training of the lower limbs at least 3 times per week in the past year.
Persons who cannot do squats due to back or knee pain.
Persons who plan to consume milk protein at present and during participation in the study.
Persons who are allergic to milk protein.
Persons who have been advised by a doctor not to exercise.
Persons who have insomnia or other sleep disorders and are currently undergoing treatment, or are taking over-the-counter sleep aids or other drugs at their own discretion.
Persons with a mental illness, such as depression, who are currently receiving treatment.
Persons with a certificate of physical or mental disability.
Persons deemed unsuitable by the principal investigator or principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1, Kagamiyama, Higashi-hiroshima
TEL
0824246585
ryotana@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1, Kagamiyama, Higashi-hiroshima
TEL
0824246585
Homepage URL
ryotana@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@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
| 2024 | Year | 03 | Month | 22 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061277
