NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedHealthy Adults
Date of first enrollment15/10/2022
Target sample size120
Countries of recruitment
Study typeInterventional
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 OutcomeAchievement rate of standard behavior in 6 months (26 weeks)
Secondary Outcome1) 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
GenderBoth
Include criteria1) 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 criteria1) 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

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
E-mail brainup@iromgroup.co.jp
Affiliation I&#039;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
E-mail akiyoshi-uchiyama@asbo.or.jp
Affiliation Medical Corporation Asbo Tokyo Asbo Clinic