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Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial

Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial - mHealth App to Increase Step Counts in Older Adults with Pre-frailty

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061313
Enrollment
270
Registered
2026-04-21
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-frailty

Interventions

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

Sponsors

Tokyo Metropolitan Institute for Geriatrics and Gerontology
Lead Sponsor
National Center for Geriatrics and Gerontology Shimane University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mean daily step count at the end of the intervention (Visit 9)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactHiroyuki Sasai

Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Team for Promoting Independence and Mental Health

sasai@tmig.or.jp03-3964-3241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026