UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062145 |
|---|---|
| Receipt number | R000071118 |
| Scientific Title | Study to verify the effectiveness of combined locomotion training and nutritional guidance |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/06 15:24:53 |
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Basic information
Public title
Study to verify the effectiveness of combined locomotion training and nutritional guidance
Acronym
Verifing the effectiveness of locomotion training and nutritional guidance
Scientific Title
Study to verify the effectiveness of combined locomotion training and nutritional guidance
Scientific Title:Acronym
Study to verify the effectiveness of combined locomotion training and nutritional guidance
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement combined locomotion training and nutritional guidance for older people living in the community who participate in preventive care classes, and to clarify its effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After 16 weeks of intervention (locomotion training), the locomotive syndrome risk test (stand-up test, two-step test, and 25-question geriatric locomotive function scale) will be evaluated.
Key secondary outcomes
Frailty (Questionnaire for Medical Checkup of Old-Old, revised J-CHS criteria), muscle strength (grip strength, ability to open a polyethylene terephthalate bottle cap), waliking speed, basic attributes (height, weight, BMI, age, sex, number of medications)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Locomotion training will be carried out every day for 16 weeks. The frequency for one-legged standing is 1 set per minute for both legs, 3 sets per day. For squats, 1 set is 5-6 times, 3 sets per day. For heel raises, 10 to 20 repetitions, 2 to 3 sets per day. In addition, nutritional guidance will be provided at baseline, and participants will be instructed to consciously increase their protein intake at breakfast.
Interventions/Control_2
Locomotion training will be carried out every day for 16 weeks. The frequency for one-legged standing is 1 set per minute for both legs, 3 sets per day. For squats, 1 set is 5-6 times, 3 sets per day. For heel raises, 10 to 20 repetitions, 2 to 3 sets per day.
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who apply for and participate in the long-term care prevention program.
Key exclusion criteria
Persons with motor dysfunction who cannot perform locomotion training, persons suspected of having dementia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Sawaya |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara, Tochigi
TEL
0287-24-3018
yohei.sawaya@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sawaya |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara, Tochigi
TEL
0287-24-3018
Homepage URL
yohei.sawaya@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Department of Physical Therapy, School of Health Sciences, International University of Health and Welfare
Address
2600-1 Kitakanemaru, Otawara, Tochigi
Tel
0287-24-3018
yohei.sawaya@gmail.com
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
| 2026 | Year | 07 | Month | 06 | 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
| 2026 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071118
