UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058664 |
|---|---|
| Receipt number | R000066532 |
| Scientific Title | Comparative Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults: An Exploratory Parallel-Group Clinical Trial Using Propensity Score Analysis |
| Date of disclosure of the study information | 2025/08/03 |
| Last modified on | 2025/08/01 11:26:08 |
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Basic information
Public title
Comparative Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults
Acronym
Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults
Scientific Title
Comparative Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults: An Exploratory Parallel-Group Clinical Trial Using Propensity Score Analysis
Scientific Title:Acronym
Effects of Exercise Combined with Nutrition versus Sleep Interventions on Locomotive Syndrome in Older Adults
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effects of an exercise plus nutrition intervention and an exercise plus sleep management intervention on locomotive function in older adults, and to explore the effectiveness of each approach.
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
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Multi-component exercises and consumption of a variety of foods, including protein foods, during 12 weeks
Interventions/Control_2
Multi-component exercises and performing sleep-promoting behaviors, during 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 65 years or older at the time of consent, and those who can provide written informed consent for participation in this study
Key exclusion criteria
Individuals who already have a habit of strength training, specifically those who have performed lower limb strength training three or more times per week in the past year.
Individuals who have previously participated in a similar study.
Individuals who are unable to stand up promptly from a chair due to low back pain or knee pain.
Individuals who have difficulty consuming the protein product provided in this study (Savas Milk Protein).
Individuals who are currently consuming "health supplements" (including foods with health claims), or plan to consume them during the study period.
Individuals whom a physician has advised to refrain from physical exercise.
Individuals currently undergoing treatment for sleep disorders, such as insomnia, or those who are self-medicating with over-the-counter sleep aids.
Individuals are currently receiving treatment for mental disorders such as depression.
Individuals who possess a physical disability certificate or a mental disability certificate.
Individuals who habitually monitor their physical activity or sleep duration using a wristband-type activity tracker.
Any other individuals deemed inappropriate for participation by the principal investigator or co-investigators.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hungu |
| Middle name | |
| Last name | Jung |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
082-257-2018
jung@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hungu |
| Middle name | |
| Last name | Jung |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL
082-257-2018
Homepage URL
jung@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
| 2025 | Year | 08 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066532
