UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060617 |
|---|---|
| Receipt number | R000068785 |
| Scientific Title | Effects of a Health Fitness Programmer Led Multicomponent Exercise Intervention on Locomotive Syndrome in Community Dwelling Older Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/02/08 |
| Last modified on | 2026/02/08 13:07:33 |
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Basic information
Public title
Effects of a Health Fitness Programmer Led Multicomponent Exercise Intervention on Locomotive Syndrome in Community Dwelling Older Adults
Acronym
Resi10 Study
Scientific Title
Effects of a Health Fitness Programmer Led Multicomponent Exercise Intervention on Locomotive Syndrome in Community Dwelling Older Adults: A Randomized Controlled Trial
Scientific Title:Acronym
MC-EX Study
Region
| Japan |
Condition
Condition
Locomotive syndrome
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effects of a Health Fitness Programmer led multicomponent exercise intervention on locomotive syndrome in community dwelling older adults using a randomized controlled trial design
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the severity of locomotive syndrome assessed by the Locomotive Syndrome Risk Test (stand-up test, two-step test, and Locomo 25), measured at baseline and at the end of the 2-month intervention period (24 sessions).
Key secondary outcomes
Changes in physical function (lower limb muscle strength, balance ability, and walking ability), physical activity level, and health-related quality of life assessed at baseline and at the end of the 2-month intervention period (24 sessions).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the locomotive training group will perform locomotive syndrome focused exercises, including exercises such as squats and single leg standing, under the supervision of a Health Fitness Programmer. The intervention will be conducted for 2 months, with a total of 24 sessions.
Interventions/Control_2
Participants in the multicomponent exercise group will engage in a multicomponent exercise program targeting muscle strength, balance, flexibility, and walking ability under the supervision of a Health Fitness Programmer. The program will be conducted for 2 months, with a total of 24 sessions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will be eligible if they meet all of the following criteria
1) Aged 60 years or older
2) No medical restriction on exercise as determined by a physician
3) Able to understand the study procedures and provide written informed consent
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria
1) Cognitive impairment defined as a score of 20 or less on the Revised Hasegawa's Dementia Scale assessed within the past 3 months
2) Difficulty in attending the assessment and exercise sessions independently on foot (unable to ambulate independently to the venue)
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Miyamoto |
Organization
Kameda Medical Center
Division name
Institute of sports sciences and medicine
Zip code
296-0041
Address
1344 Higashi cho Kamogawa City Chiba Japan
TEL
04-7099-2345
miyamoto1105@gmail.com
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Miyamoto |
Organization
Kameda Medical Center
Division name
Institute of sports sciences and medicine
Zip code
2960041
Address
1344 Higashi cho Kamogawa City Chiba 296-0041Japan
TEL
04-7099-2345
Homepage URL
miyamoto1105@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
JAPAN HEALTH PROMOTION & FITNESS FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Committee, Kameda General Hospital, Medical Corporation Tesshokai
Address
929 Higashi-cho, Kamogawa City, Chiba 296-8602, Japan
Tel
04-7099-2211
clinical_research@kameda.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
| 2026 | Year | 02 | Month | 08 | 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
64
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068785
