UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057345 |
|---|---|
| Receipt number | R000065540 |
| Scientific Title | Study to verify the effectiveness of locomotion training |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/19 16:55:47 |
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Basic information
Public title
Study to verify the effectiveness of locomotion training
Acronym
Study to verify the effectiveness of locomotion training
Scientific Title
Study to verify the effectiveness of locomotion training
Scientific Title:Acronym
Study to verify the effectiveness of locomotion training
Region
| Japan |
Condition
Condition
Individuals using day care rehabilitation with Support Level 1 or 2
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of locomotion training in older adults requiring support levels who use day care rehabilitation. Participants will be divided into two groups: one receiving only the standard rehabilitation provided in day care rehabilitation and the other receiving locomotion training in addition to the standard rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sarcopenia (grip strength, walking speed, and body composition) will be assessed at baseline (before the intervention), three months after baseline (post-intervention), and six months after baseline.
Key secondary outcomes
Locomotive syndrome (Stand-up Test, Two-step Test, and GLFS-25), frailty (Simplified Frailty Index), lower limb muscle strength (CS-30), and depression (GDS-15) will be assessed at baseline (before the intervention), three months after baseline (post-intervention), and six months after baseline.
Baseline characteristics, including age, height, weight, BMI, number of medications, comorbidities (Charlson Comorbidity Index), family composition, nutritional status (MNA-sf), and cognitive function (MMSE, HDS-R), will be assessed before the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention Group:
In addition to standard day care rehabilitation, locomotion training will be conducted from April 1, 2025, to June 30, 2025.
The locomotion training consists of:
Single-leg standing: 1 set of 1 minute on each leg, 3 sets per day
Squats: 1 set of 5-6 repetitions, 3 sets per day
These exercises will be performed daily for three months.
Interventions/Control_2
Control Group:
Standard day care rehabilitation only
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 with Support Level 1 or 2 using day care rehabilitation
Key exclusion criteria
Individuals who use a wheelchair in daily life
Individuals who use a walker in daily life
Dementia
Individuals at high risk of falling when performing locomotion training (Ataxia,etc)
Target sample size
29
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
3248501
Address
Kitakanemaru 2600-1, Otawara, Tochigi
TEL
0287243018
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
3248501
Address
Kitakanemaru 2600-1, Otawara, Tochigi
TEL
0287243018
Homepage URL
yohei.sawaya@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
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
International University of Health and Welfare
Address
Kitakanemaru 2600-1, Otawara, Tochigi
Tel
0287243018
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
| 2025 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065540
