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An exploratory clinical research confirming of the efficacy and safety of behavior modification therapy with healthcare-focused app in healthy adult subjects

An exploratory clinical research confirming of the efficacy and safety of behavior modification therapy with healthcare-focused app in healthy adult subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220364
Enrollment
120
Registered
2022-10-06
Start date
2022-10-15
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

Healthy Adults

Interventions

Confirm eligibility after a Pre-Examination Test, intervention with the research device will be started after registration. Moreover, a head MRI image analysis in BrainSuite will be performed within 1

Sponsors

Uchiyama Akiyoshi
Lead Sponsor
CogSmart Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy male and female subjects who are 35 to 65 years of age. 2) Subjects who are from the precontemplation to the preparation stage on the Transtheoretical Model (TTM model). 3) Subjects who are in constant smartphone (iPhone) user.

Exclusion criteria

Exclusion criteria: 1) Those who are inappropriate for a head MRI examination. 2) Those who are not using an iPhone updated to the latest version of iOS 15.0 or higher. 3) Those who have exercise habits of 30 minutes or more at least twice a week at the time of obtaining consent. 4) Those who are limited exercising for some reason. 5) Those with severe cardiovascular disorders (CVDs) such as myocardial infarction (MI), severe hypertension, and orthopedic problems such as bone and joint diseases. 6) Those with metal or latex (rubber) allergies. 7) Those with skin disorders at the wristband wearing site. 8) Those with mental illness such as schizophrenia or depression or under treatment. 9) Female who are pregnant, may be pregnant, or wish to become pregnant during the study. 10) Those who are judged by the principal investigator or the sub investigator to be inappropriate as research subjects.

Design outcomes

Primary

MeasureTime frame
Achievement rate of standard behavior in 6 months (26 weeks)

Secondary

MeasureTime frame
1) Cognitive Functions Test: Cantab (Cambridge Cognition Ltd) are used, of the following 3 assessment scales on higher cognitive functions. (1) Paired Associates Learning (PAL) (2) Spatial Working Memory (SWM) (3) Rapid Visual Information Processing (RVP) 2) Grey matter volume of the hippocampus and cerebrum (After the 3DT1 head MR imaging, it is analyzed and measured by academically verified software.) 3) Exercise time for each traning intensity

Contacts

Public ContactSatoru Yokotsuka

I'cros Co., Ltd.

brainup@iromgroup.co.jp+81-92-406-8278

Outcome results

None listed

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