UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062705 |
|---|---|
| Receipt number | R000071797 |
| Scientific Title | Construction and application of a smart aging exercise promotion system in community parks |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/27 02:34:39 |
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Basic information
Public title
Individualized Prescription Using Outdoor Fitness Equipment: A Two-Phase Intervention Study in Older Adults
Acronym
OFE-Intervention
Scientific Title
Construction and application of a smart aging exercise promotion system in community parks
Scientific Title:Acronym
SmartAging-Park
Region
| Asia(except Japan) |
Condition
Condition
Healthy older adults; community-dwelling older adults aged 65 years and above
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the effects of a two-phase community park outdoor fitness equipment (OFE) intervention on physical function and the sustainability of physical activity behaviour among community-dwelling older adults. Phase 1 investigated the effects of a 12-week structured supervised OFE exercise program on body composition and physical function. Phase 2 evaluated whether individualized exercise prescription provided following program completion could promote continued autonomous OFE engagement and produce superior physical function outcomes compared with a control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function assessed by grip strength (kg), 5 Times Sit-to-Stand (seconds), 3m Timed Up and Go (seconds), 3m walking speed (m/s), and 6m walking speed (m/s), measured at baseline, post-intervention (12 weeks), and 6-week follow-up (18 weeks).
Key secondary outcomes
Body composition including Body Fat Percentage (%), Body Mass Index (kg/m2), and Appendicular Skeletal Muscle Mass Index (kg), measured via Bioelectric Impedance Analysis at baseline, 12 weeks, and 18 weeks.
Autonomous practice frequency during Phase 2 (6-week follow-up), assessed by park visit frequency (number of visits) and mean session duration (minutes) recorded via an electronic key fob-based clock-in system.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Phase 1 (Weeks 1-12): All participants received a 12-week structured supervised OFE exercise program, delivered twice weekly. Each session lasted approximately 90 minutes, incorporating muscular strength, cardiorespiratory endurance, balance, and flexibility training using outdoor fitness equipment. Phase 2 (Weeks 13-18): The experimental group (EG) received an individualized exercise prescription based on their Phase 1 post-intervention physical function assessment results, targeting areas of relative weakness in upper limb strength, lower limb strength, or balance.
Interventions/Control_2
Phase 1 (Weeks 1-12): Same as the experimental group. Phase 2 (Weeks 13-18): The control group (CG) had ongoing unsupervised access to the outdoor exercise park without receiving any individualized exercise prescription.
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
Aged 65 years or older and community-dwelling (not residing in institutional settings such as nursing homes)
Capable of independent ambulation without the assistance of others or the use of mobility aids
Completion of the Physical Activity Readiness Questionnaire (PAR-Q+) with no major medical conditions, use of antidepressant medications, or diagnosis of Alzheimer's disease
Not concurrently enrolled in any other structured exercise programs during the study period
Key exclusion criteria
Residing in institutional settings (e.g., nursing homes)
Requiring mobility aids or assistance from others for ambulation
Diagnosed with major medical conditions, currently using antidepressant medications, or diagnosed with Alzheimer's disease (unless medical clearance obtained)
Concurrently enrolled in other structured physical activity programs
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Shao-Hsi |
| Middle name | |
| Last name | Chang |
Organization
National Taiwan Normal University
Division name
Department of Physical Education and Sports Sciences
Zip code
106
Address
162, Heping East Road Section 1, Taipei, Taiwan
TEL
+886-2-2369-1966
t08016@ntnu.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, Taiwan (R.O.C.)
TEL
04-23590121
Homepage URL
https://resume.thu.edu.tw/portfolio/main/yichien/B00
yichien@thu.edu.tw
Sponsor or person
Institute
National Taiwan Normal University, Department of Physical Education and Sports Sciences
Institute
Department
Personal name
Funding Source
Organization
National Science and Technology Council, Taiwan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research 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 | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
43
Results
Phase 1 (n=39): Significant improvements in grip strength, 3m TUG, and 3m walking speed (p<.05). No significant changes in 5 Times Sit-to-Stand and 6m walking speed (p>.05). Body fat percentage and BMI increased significantly (p<.01). Phase 2 (EG: n=18, CG: n=18): EG demonstrated significantly greater appendicular muscle mass (p=.015), lower limb muscle strength by 5 Times Sit-to-Stand (p=.020), and longer mean autonomous practice duration (p=.032) compared with CG.
Results date posted
| 2026 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 39 participants completed Phase 1 assessments (mean age: 70.4 +/- 4.7 years; 84.6% women). Educational level ranged from primary school to college or above. Fall history in the preceding year was reported by 43.6% of participants. For Phase 2, 36 participants completed follow-up assessments (EG: n=18, CG: n=18). No statistically significant between-group differences were observed at baseline for any sociodemographic variable (all p>.05).
Participant flow
50 older adults were screened. 43 enrolled following the introductory session. Phase 1: 4 participants withdrew (3 due to personal reasons, 1 sustained a fall at home before post-testing), yielding 39 participants for analysis (attrition rate: 9.30%). 2 participants were excluded from body composition assessments due to implanted cardiac stents (n=37 for body composition; n=39 for all other measures). Phase 2: 3 additional participants withdrew due to COVID-19 diagnosis or accidental injury, leaving 36 participants (EG: n=18, CG: n=18). Body composition data available for 33 participants (EG: n=16, CG: n=17).
Adverse events
One participant sustained a fall at home the day before post-testing and was unable to complete Phase 1 post-intervention assessment. No intervention-related adverse events or injuries occurred during the structured exercise sessions. No sessions were cancelled due to inclement weather or excessive heat during the intervention period.
Outcome measures
Primary outcomes: Physical function assessed by grip strength (kg), 5 Times Sit-to-Stand (seconds), 3m Timed Up and Go (seconds), 3m walking speed (m/s), and 6m walking speed (m/s), measured at baseline, post-intervention (12 weeks), and 6-week follow-up (18 weeks). Secondary outcomes: (1) Body composition including Body Fat Percentage (%), Body Mass Index (kg/m2), and Appendicular Skeletal Muscle Mass Index (kg), measured via Bioelectric Impedance Analysis at baseline, 12 weeks, and 18 weeks. (2) Autonomous practice frequency during Phase 2, assessed by park visit frequency (number of visits) and mean session duration (minutes) recorded via an electronic key fob-based clock-in system.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
This trial was retrospectively registered. Data collection was completed in 2022. The study was conducted at Sanmin Park, Sanchong District, New Taipei City, Taiwan. IRB approval was obtained from the Research Ethics Center of National Taiwan Normal University (REC number: 202012HM028, approval date: January 18, 2021).
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071797
