Tokyo, April 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061389) titled 'A feasibility study on the effects of wearable devices on behavioral change and health outcomes in frail individuals' on April 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokyo Metropolitan Institute for Geriatrics and Gerontology

Condition: Condition - prefrailty and frailty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To be conducted a feasibility study to determine the feasibility of implementing the intervention and the effect of the intervention on outcome measures, prior to a randomized controlled trial of intervention using a wearable device and a behavior change application Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 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 change depending on the participant's behavioral stage and application usage.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key 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. Key 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. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 10 Day Date of IRB - 2026 Year 02 Month 10 Day Anticipated trial start date - 2026 Year 04 Month 06 Day Last follow-up date - 2026 Year 07 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069361

Disclaimer: Curated by HT Syndication.