UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053650 |
|---|---|
| Receipt number | R000061232 |
| Scientific Title | Effect of One-Leg Standing Exercise Incorporated into Activities of Daily Living on Fall Prevention in Community-Dwelling Older People: A Pilot Study |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/19 19:23:01 |
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Basic information
Public title
Effect of One-Leg Standing Exercise Incorporated into Activities of Daily Living on Fall Prevention in Community-Dwelling Older People
Acronym
Effect of One-Leg Standing Exercise Incorporated into Activities of Daily Living on Fall Prevention
Scientific Title
Effect of One-Leg Standing Exercise Incorporated into Activities of Daily Living on Fall Prevention in Community-Dwelling Older People: A Pilot Study
Scientific Title:Acronym
Effect of One-Leg Standing Exercise Incorporated into Activities of Daily Living on Fall Prevention: A Pilot Study
Region
| Japan |
Condition
Condition
Community-Dwelling Older People
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of incorporating one-leg standing into daily activities to prevent falls in community-dwelling older people
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of falls, number of falls, injuries at the time of fall, time of first fall
Key secondary outcomes
TUG, Five-repetition sit-to-stand test, grip strength, Mini-cog, life satisfaction index, GDS15
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants perform one-legged standing exercises integrated into daily activities in their homes for 6 months. Exercises were performed by incorporating one-legged standing into daily activities at home, such as washing hands, preparing meals, and cleaning the house, as determined by the participants. Daily exercise is recommended. The one-leg stand was initially performed with both hands supporting a wall, desk, or chair. When participants subjectively found it easier, they were allowed to evolve to one-handed support or no hand support.
Interventions/Control_2
Continuation of usual life
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
65 years of age or older
Not certified as requiring long-term care
Not diagnosed with dementia
Able to stand on one leg
Able to communicate
Key exclusion criteria
Those who are prohibited from exercising by their doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
TEL
072-950-2111
yokoikat@omu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
TEL
072-950-2111
Homepage URL
yokoikat@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Committee on Research Ethics, The Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
Tel
072-950-2111
yokoikat@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
| 2024 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061232
