JRCT ID: jRCTs032220364
Registered date:06/10/2022
An exploratory clinical research confirming of the efficacy and safety of behavior modification therapy with healthcare-focused app in healthy adult subjects
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | Healthy Adults |
Date of first enrollment | 15/10/2022 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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 week after registration, it will be interlocked with the app during the next 3 business days. The observation period is 6 months (26 weeks), subjects carry out exercises instructed by the research equipment, recording daily activity status. In addition, the timeline for confirming the usability of the app is 4 weeks after the start of use (telephonically) and 12, 26 weeks after, or at the time of discontinuation (visit hospital). |
Outcome(s)
Primary Outcome | Achievement rate of standard behavior in 6 months (26 weeks) |
---|---|
Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 35age old |
---|---|
Age maximum | <= 65age old |
Gender | Both |
Include 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. |
Exclude 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. |
Related Information
Primary Sponsor | Uchiyama Akiyoshi |
---|---|
Secondary Sponsor | CogSmart Co., Ltd. |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Satoru Yokotsuka |
Address | 9F ACROS Fukuoka, 1-1-1 Tenjin, Chuo-ku, Fukuoka Fukuoka Japan 810-0001 |
Telephone | +81-92-406-8278 |
brainup@iromgroup.co.jp | |
Affiliation | I'cros Co., Ltd. |
Scientific contact | |
Name | Akiyoshi Uchiyama |
Address | 24F KYOBASHI EDOGRAND, 2-2-1 Kyobashi, Chuo-ku, Tokyo Tokyo Japan 104-0031 |
Telephone | +81-3-6665-0518 |
akiyoshi-uchiyama@asbo.or.jp | |
Affiliation | Medical Corporation Asbo Tokyo Asbo Clinic |