UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055631 |
|---|---|
| Receipt number | R000063575 |
| Scientific Title | Study to verify the effectiveness of locomotion training |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2026/01/17 15:11:39 |
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Basic information
Public title
Study to verify the effectiveness of locomotion training
Acronym
Verifing 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
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement locomotion training 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 12 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), muscle strength (grip strength, ability to open a polyethylene terephthalate bottle cap), basic attributes (height, weight, BMI, age, sex)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Locomotion training will be carried out every day for 12 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.
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
| 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
30
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
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
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
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2024 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/453168-locomotion-training-in-a-care-prevention-program-for-communit
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/453168-locomotion-training-in-a-care-prevention-program-for-communit
Number of participants that the trial has enrolled
14
Results
Three participants who were not classified as having LS pre-intervention remained in the non-LS category. Among the 11 participants who had LS pre-intervention, four individuals (36.4%) showed improvement in their LS stage, while seven (63.6%) remained in their LS stage. No participant experienced worsening of their LS stage. The GLFS-25 score improved significantly post-intervention [pre-intervention: median 6.5 (interquartile range: 3.0-14.3); post-intervention: median 4.5 (2.0-9.3); p = 0.011].
Results date posted
| 2026 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This interventional study employed a pre-post design and was conducted between September and December 2024. The participants were 14 women (mean age: 76.5 years) who participated in a long-term care prevention program. A 76-day exercise intervention consisting of LT was implemented.
Participant flow
This interventional study employed a pre-post design and was conducted between September and December 2024. The participants were 14 women who participated in a long-term care prevention program. A 76-day exercise intervention consisting of LT was implemented.
Adverse events
None.
Outcome measures
LS was assessed pre- and post-intervention using the stand-up test, the two-step test, and the 25-item Geriatric Locomotive Function Scale (GLFS-25).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 12 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 12 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063575
