UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058960 |
|---|---|
| Receipt number | R000067384 |
| Scientific Title | Feasibility and Functional Effects of a Semi-Automated Personalized Exercise Program Based on the Timed Up and Go (TUG) Test |
| Date of disclosure of the study information | 2025/09/02 |
| Last modified on | 2025/09/02 09:56:28 |
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Basic information
Public title
Feasibility and Functional Effects of a Semi-Automated Personalized Exercise Program Based on the Timed Up and Go (TUG) Test
Acronym
A study about a Semi-Automated Personalized Exercise Program Based on the Timed Up and Go (TUG) Test
Scientific Title
Feasibility and Functional Effects of a Semi-Automated Personalized Exercise Program Based on the Timed Up and Go (TUG) Test
Scientific Title:Acronym
A study about a Semi-Automated Personalized Exercise Program Based on the Timed Up and Go (TUG) Test
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the feasibility and effectiveness of a semi-automated individualized exercise prescription system (TUG system), which we developed based on the Timed "Up and Go" (TUG) test, by implementing it in a small number of participants.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implementation rate of exercise after 3 months and 7 months
Key secondary outcomes
Accidents of falling, and occurrence of pain during exercises after 3 months and 7 months, and walking speed, sit-to-stand test, and tandem balance test after 7 months
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants will receive exercise instruction based on an individualized exercise program generated by the TUG system. For those identified as high-risk, the program will be re-evaluated and modified by a physical therapist. Participants will be instructed to perform the individualized exercises at home.
The TUG system assesses physical function by measuring the time required to complete each component of the TUG test: sit-to-stand, straight walking, turning, and sitting down. Based on the measured times, it will calculate scores representing gait function, lower limb muscle strength, and balance function. After the assessment, a printed pamphlet presenting an individualized exercise program-adjusted in difficulty according to each functional score will be generated. Furthermore, if a participant is classified as high-risk based on the assessment results, a physical therapist will conduct an additional evaluation and revise the program accordingly. A printed sheet describing the revised program will then be sent to the participant by mail.
The intervention period will be set at three months, with a frequency of at least three sessions per week. Participants will be encouraged to continue the exercises even after the three-month period has ended.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults who are independent in daily living
Key exclusion criteria
*Individuals who have been certified as requiring long-term care
*Individuals with a history of neurological disorders that affect balance function (e.g., stroke, Parkinson's disease)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Misu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133584
s-misu@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Misu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe
TEL
0784133584
Homepage URL
s-misu@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Physical Therapy
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
Konan Women's University Research Ethics Committee
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
Tel
078-413-3972
gakuken@konan-wu.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 | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2027 | 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 | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067384
