UMIN-CTR Clinical Trial

Basic information
Public title	A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Acronym	A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Scientific Title	A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Scientific Title:Acronym	A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Region	Japan

Condition
Condition	none
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to confirm the effect of using SNS (effect on continuation of exercise and effect on motor function) in an environment where there are few opportunities for face-to-face instruction.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to confirm the effect of using SNS (effect on continuation of exercise and effect on motor function) in an environment where there are few opportunities for face-to-face instruction. Trainers usually teach participants about 1-2 hours (for example, twice a month) at an exercise event. but, this method does not lead to the establishment of exercise effects, so a more effective approach is needed. This time, we will collect basic data on changes in cognitive behavior and motor function from groups that participated only in the event and groups that participated in the exercise event and watched SNS videos. From the results, we will investigate the effectiveness of using SNS.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise rate = days of exercise / days of exercise
Key secondary outcomes	Confirm the change in consciousness (self-efficacy) at the start and end by questionnaire. In addition, abdominal circumference and BMI changes at the start and end, changes in walking function, changes in physical fitness measurement

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The research period (intervention period) is 6 weeks (42 days), and participants participate in 4 exercise events (first time, 2nd week, 4th week, 6th week), provide exercise guidance for trainers, and use a smartphone (smartphone). Exercise videos are distributed to the LINE app) twice a week.
Interventions/Control_2	The research period (intervention period) will be 6 weeks (42 days), and participants will participate in 4 exercise events (1st, 2nd, 4th, and 6th weeks) and trainers will be instructed in exercise.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Healthy people: Those who can exercise training for the elderly 2 Age must be between 50 and 85 years 3 Those who can walk independently and perform simple exercises in daily life, 4 I use the LINE app on my smartphone everyday. 5 Persons who have received sufficient explanation in participating in this study and obtained written consent at their own discretion.
Key exclusion criteria	1 Person who has a disease and is prohibited from exercising by a doctor 2 Persons requiring care and support 3 Excluded persons (those who cannot walk or stand on one leg) judged by the person in charge of the exercise event implementation facility and experts (health teachers) 4 Persons wearing internal equipment such as pacemakers 5 Others who are judged to be inappropriate by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name hidetaka Middle name Last name hisano
Organization	be awake company limited
Division name	-
Zip code	253-0054
Address	2-11-24-308 higashikaiganminami, chigasaki, Kanagawa 253-0054, Japan
TEL	0467-33-4388
Email	h.hisano@beawake.co.jp

Public contact
Name of contact person	1st name hidetaka Middle name Last name hisano
Organization	be awake company limited
Division name	-
Zip code	253-0054
Address	2-11-24-308 higashikaiganminami, chigasaki, Kanagawa 253-0054, Japan
TEL	0467-33-4388
Homepage URL
Email	h.hisano@beawake.co.jp

Sponsor
Institute	be awake company limited
Institute
Department

Funding Source
Organization	be awake company limited
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NPO community health plan
Address	2-7-23 nanokamachi, yamagata-city, yamagata 990-0042, Japan
Tel	0463-93-1121
Email	ayoko5270@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 10 Day
Date of IRB	2022 Year 06 Month 16 Day
Anticipated trial start date	2022 Year 06 Month 26 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 05 Day
Last modified on	2022 Year 07 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055024