UMIN-CTR 臨床試験登録情報の閲覧
| Unique ID issued by UMIN | UMIN000063005 |
|---|---|
| Receipt number | R000072128 |
| Scientific Title | Localized Strategies for Implementing Vigorous Intermittent Lifestyle Physical Activity in Older Adults: A Non-Randomized Comparison of Structured Interval Walking Training and a No-Intervention Control Group |
| Date of disclosure of the study information | 2026/09/20 |
| Last modified on | 2026/09/20 23:06:58 |
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Basic information
Public title
A non-randomized comparison of structured interval walking training versus no intervention on functional fitness and body composition in older adults
Acronym
IWT-CG
Scientific Title
Localized Strategies for Implementing Vigorous Intermittent Lifestyle Physical Activity in Older Adults: A Non-Randomized Comparison of Structured Interval Walking Training and a No-Intervention Control Group
Scientific Title:Acronym
Localized Strategies for Implementing Vigorous Intermittent Lifestyle Physical Activity in Older Adults: A Non-Randomized Comparison of Structured Interval Walking Training and a No-Intervention Control Group (IWT-CG)
Region
| Asia(except Japan) |
Condition
Condition
Healthy community-dwelling older adults
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare functional fitness, body composition, and psychosocial outcomes over a 12-week period between older adults participating in a structured interval walking training program (WalkPacer Pro application, 1-minute and 3-minute alternating fast and slow walking cycles) and a non-randomized control group receiving no walking intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in 30-second sit-to-stand test score from baseline to week 12.
Key secondary outcomes
Change in timed up-and-go test and single-leg stance test performance from baseline to week 12; change in body composition parameters measured by bioelectrical impedance analysis (InBody), including body fat percentage, skeletal muscle mass, and body mass index, from baseline to week 12; change in exercise self-efficacy score and self-rated health score from baseline to week 12.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Structured interval walking training using the WalkPacer Pro mobile application (1-minute or 3-minute alternating fast and slow walking cycles), self-administered over a 12-week period, with no prescribed minimum or maximum weekly training duration.
Interventions/Control_2
No walking intervention was provided. Participants continued their usual daily activities without any structured exercise program during the 12-week study period.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling adults aged 60 years or older; able to walk independently without assistive devices; not currently participating in any structured exercise intervention program.
Key exclusion criteria
Presence of cognitive impairment precluding informed consent; unstable cardiovascular disease or other medical contraindication to functional fitness testing.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YI CHIEN |
| Middle name | |
| Last name | YU |
Organization
Tunghai University
Division name
Department of Physical Education
Zip code
407224
Address
No. 1727, Sec. 4, Taiwan Boulevard, Xitun District, Taichung City 407224, Taiwan R.O.C
TEL
04-23590121
yichien@thu.edu.tw
Public contact
Name of contact person
| 1st name | YI CHIEN |
| Middle name | |
| Last name | YU |
Organization
Tunghai University
Division name
Department of Physical Education
Zip code
407224
Address
No. 1727, Sec. 4, Taiwan Boulevard, Xitun District, Taichung City 407224, Taiwan R.O.C
TEL
04-23590121
Homepage URL
https://resume.thu.edu.tw/portfolio/main/yichien
yichien@thu.edu.tw
Sponsor or person
Institute
Tunghai University
Institute
Department
Personal name
_ Yu
Funding Source
Organization
National Science and Technology Council, Taiwan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
National Science and Technology Council, Taiwan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rese arch Ethics Center, National Taiwan Normal University
Address
162, Heping East Road Section 1, Taipei, Taiwan
Tel
+886-2-7749-1903
ntnurec@ntnu.edu.tw
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 | 09 | Month | 20 | 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 | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 21 | 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 | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072128
