UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061313 |
|---|---|
| Receipt number | R000070154 |
| Scientific Title | Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/19 23:57:41 |
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Basic information
Public title
Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial
Acronym
mHealth App to Increase Step Counts in Older Adults with Pre-frailty
Scientific Title
Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial
Scientific Title:Acronym
mHealth App to Increase Step Counts in Older Adults with Pre-frailty
Region
| Japan |
Condition
Condition
Pre-frailty
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effectiveness of the mobile health (mHealth) app "Online Kayoinoba" in increasing step counts among community-dwelling older adults with pre-frailty in Tokyo, Aichi Prefecture, and Shimane Prefecture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Mean daily step count at the end of the intervention (Visit 9)
Key secondary outcomes
1. Mean daily step count at Visit 12
2. Blood pressure, pain status, and fall history at Visits 9 and 12
3. Physical function at Visits 9 and 12 (Chair Stand Test, 8-Foot Up and Go Test, and 2-minute Step in Place Test)
4. Health-related quality of life at Visits 9 and 12 (SF-36 PCS, RCS, and MCS)
5. Home exercise self-efficacy, exercise self-efficacy, functional status (KCL), depressive symptoms (GDS-15), digital health literacy (DHLI), and dietary variety (DVS) at Visits 9 and 12
6. Accelerometer-derived gait and sleep parameters at Visits 9 and 12
7. Adverse events during the intervention period
8. Adherence (discontinuation/dropout rate, attendance at face-to-face instruction sessions, app use frequency, app use duration, login status, and use of each content component)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will receive an intervention designed to support use of the Online Kayoinoba app. First, they will attend one standardized smartphone-use training session. They will then receive eight weekly face-to-face instructional sessions over the 8-week intervention period. At each visit, a specialist will provide a 60-minute lecture on the proper use of the Online Kayoinoba app and its functions. The content will include app installation, how to earn points, the walking function, exercise videos, dietary check, communication functions, health check, and an overall review of these functions. In addition, the same health education provided to the control group will also be delivered. After the intervention period, an approximately 67-week follow-up period will be conducted. During follow-up, a newsletter containing information useful for health and daily living will be mailed every 4 weeks to support continued study participation. In the intervention group, the in-app group chat will also be used once a week after Visit 9 to encourage participants to open the app regularly.
Interventions/Control_2
Participants in the control group will first receive one smartphone-use training session identical to that provided to the intervention group. They will then attend eight weekly visits over the 8-week intervention period to receive health education. The educational content will cover frailty awareness, exercise, nutrition, sleep, social participation, and a general review related to frailty prevention and management. After the intervention period, participants will enter an approximately 67-week follow-up period. During follow-up, a newsletter containing information useful for health and daily living will be mailed every 4 weeks to support continued study participation. To minimize contamination, face-to-face instructional sessions will be conducted separately for the intervention and control groups.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 65 years or older at the time of providing informed consent
2. Adults classified as having pre-frailty (score 1-2) based on the revised Japanese version of the Cardiovascular Health Study criteria (J-CHS), assessed within 12 months before informed consent
3. Adults who provide written informed consent to participate in the study
Key exclusion criteria
1. Individuals who use a smartphone on fewer than 5 days per week
2. Individuals who have been diagnosed with and are receiving treatment for dementia
3. Individuals with a history of, or currently receiving treatment for, neurological disorders such as depression, Parkinson's disease, or stroke
4. Individuals who are currently using the Online Kayoinoba app
5. Individuals unable to undergo physical function testing
6. Individuals with impairment in basic activities of daily living
7. Individuals who have been advised by their primary care physician not to engage in exercise, other than light exercise
8. Individuals who have experienced angina or myocardial infarction within the past 3 months, have a history of cardiac surgery, are receiving palliative care for a terminal illness, or already have plans for surgery or hospitalization during the study period
9. Individuals whom the principal investigator, co-investigators, or study physicians judge to be ineligible for participation in this study
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sasai |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
sasai@tmig.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sasai |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
Homepage URL
sasai@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Shimane University
Name of secondary funder(s)
National Center for Geriatrics and Gerontology, Longevity Sciences Research and Development Fund
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi, Tokyo
Tel
03-3964-3241
rinsyoushiken@tmghig.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
| 2026 | Year | 04 | Month | 21 | 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
| 2026 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070154
