UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058997 |
|---|---|
| Receipt number | R000067469 |
| Scientific Title | Effects of Agility Training Using Seated Opening and Closing Stepping on Muscle Power and Balance Ability |
| Date of disclosure of the study information | 2025/09/10 |
| Last modified on | 2025/09/04 18:53:00 |
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Basic information
Public title
Effects of Agility Training Using Seated Opening and Closing Stepping on Muscle Power and Balance Ability
Acronym
Effects of Agility Training Using Seated Opening and Closing Stepping on Muscle Power and Balance Ability
Scientific Title
Effects of Agility Training Using Seated Opening and Closing Stepping on Muscle Power and Balance Ability
Scientific Title:Acronym
Effects of Agility Training Using Seated Opening and Closing Stepping on Muscle Power and Balance Ability
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on agility training that can be performed in a stable seated position, this study aims to clarify its effectiveness as a new intervention method for the elderly and those requiring support by verifying its effects on muscle power, agility, and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-time stand-up test, seated opening/closing stepping test, center of gravity sway measurement (total trajectory length, rectangular area, velocity, density, lateral center, anterior-posterior center, effective area, center of gravity trajectory), lower limb muscle strength (abductor strength, adductor strength)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Agility Training Intervention: Perform three sets of the seated opening-closing stepping test. Each set follows the sequence: intervention (20 sec), rest (20 sec), intervention (20 sec), rest (20 sec), intervention (20 sec), with a 60 second interval between sets. The intervention is conducted three times per week.
Interventions/Control_2
No intervention (control)
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Approximately healthy adults who provided informed consent will participate. Recruitment of research subjects will be conducted by the principal investigator and co-investigators through public recruitment targeting students of Hiroshima City Gakuen University. This will involve posting recruitment notices on web bulletin boards and conducting outreach during homeroom periods. Prospective participants who express interest in cooperating with the research through recruitment notices or other means will receive a thorough explanation of the research content using an explanatory document. Only those who confirm their understanding of the research content and provide written informed consent will be enrolled as subjects.
Key exclusion criteria
Individuals who did not provide consent and those diagnosed with lower limb musculoskeletal disorders were excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikura |
Organization
Hiroshima Cosmopolitan University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
731-3166
Address
3-2-1 Otsuka Higashi, Asaminami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
ishikura@hcu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikura |
Organization
Hiroshima Cosmopolitan University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
731-3166
Address
3-2-1 Otsuka Higashi, Asaminami Ward, Hiroshima City, Hiroshima Prefecture
TEL
082-849-6883
Homepage URL
ishikura@hcu.ac.jp
Sponsor or person
Institute
Hiroshima Cosmopolitan University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hiroshima Cosmopolitan University Ethics Review Committee
Address
3-2-1 Ozukahigashi, Asaminami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-849-6883
makitar@hcu.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 | 09 | Month | 10 | 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
30
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 | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067469
