UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042808 |
|---|---|
| Receipt number | R000048860 |
| Scientific Title | Effects of Hip- and Ankle-Focused Training on Mobility and Lower Extremity Function in Community-Dwelling Older Adults: A Non-Randomized Comparative Intervention Study |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2026/08/19 16:09:52 |
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Basic information
Public title
Effects of Hip- and Ankle-Focused Training on Mobility in Community-Dwelling Older Adults
Acronym
Effects of Hip- and Ankle-Focused Training on Mobility in Community-Dwelling Older Adults
Scientific Title
Effects of Hip- and Ankle-Focused Training on Mobility and Lower Extremity Function in Community-Dwelling Older Adults: A Non-Randomized Comparative Intervention Study
Scientific Title:Acronym
Effects of Hip- and Ankle-Focused Training on Mobility and Lower Extremity Function
Region
| Japan |
Condition
Condition
community-dwelling healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of hip-focused and ankle-focused exercise programs on lower extremity function and mobility performance in community-dwelling older adults and to explore whether joint-specific exercise produces differential functional benefits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Gait function: usual gait speed, maximum gait speed, step length, and cadence.
* Mobility: Five-Times Sit-to-Stand Test (5STS), Functional Reach Test (FRT), Timed Up and Go Test (TUG), and Two-Step Test.
* Lower extremity function: muscle strength and movement velocity of hip extension, knee extension, and ankle plantar flexion.
Key secondary outcomes
history of falls, activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Hip joint-focused training
Interventions/Control_2
Ankle joint-focused training
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
age 65 years and older
Key exclusion criteria
Patients with severe dementia
Patients with moderate or severe respiratory disease
Patients with moderate or severe cardiovascular disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
iwata@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka city, Osaka, Japan
TEL
06-6167-1247
Homepage URL
yamamoto-reha@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hankyu Hanshin Holdings, Inc.
WellBeing Hankyu Hanshin Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
2-1-132 Morinomiya, Joto-ku, Osaka city, Osaka, Japan
Tel
06-6167-1247
yamamoto-reha@omu.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
| 2020 | Year | 12 | Month | 23 | 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
20
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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048860
