A feasibility study on the effects of wearable devices on behavioral change and health outcomes in frail individuals

Verification of the effects of wearable devices on behavioral change and health outcomes in pre-frail and frail individuals: A feasibility study for a randomized controlled trial - A feasibility study of the effects of wearable devices in improving pre-frailty and frailty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061389

Enrollment

Registered

2026-04-27

Start date

2026-04-06

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

prefrailty and frailty

Interventions

For three months, participants wear insole- and wristband-type devices. Measurement data from the devices are displayed in a behavior change application. The contents displayed in the application chan

s behavioral stage and application usage.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants in the 2011 and 2017-2019 cohorts of the Otassha Study. 2. Individuals who meet the criteria for frailty (8 or more items) or pre-frailty (4-7 items) on the Kihon Checklist. 3. Individuals who own a smartphone. 4. Individuals who wish to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Individuals who are unable to participate in the pre- and post-assessments. 2. Individuals diagnosed with dementia or prescribed anti-dementia medication. 3. Individuals with impaired basic activities of daily living. 4. Individuals whose primary care physician has prohibited exercise (except light exercise). 5. Individuals with unstable or severe illnesses. 6. Individuals who have experienced angina pectoris, myocardial infarction, or cardiac surgery within the past three months, or individuals with terminal illnesses or receiving palliative care. 7. Individuals participating in specific rehabilitation programs. 8. Individuals currently participating in or planning to participate in other clinical trials during this study. 9. Individuals planning to participate in research using other mobile health apps during this study. 10. Individuals without a smartphone. 11. Individuals with difficulty communicating in Japanese. 12. Individuals deemed ineligible for participation by the principal investigator. 13. Individuals who are unable to provide consent to participate in the study.

Design outcomes

Primary

Measure	Time frame
frailty based on Kihon Checklist	—

Countries

Japan

Contacts

Public ContactHisashi Kawai

Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Team for Human Care

hkawai@tmig.or.jp03-3964-3241

Outcome results

None listed

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