UMIN-CTR Clinical Trial

Basic information
Public title	The development of IOT system to promote habitual exercise training
Acronym	The promotion of habitual exerrcise by IOT
Scientific Title	The development of a smartphone application to acelerate the adherence to interval walking training
Scientific Title:Acronym	The promotion of interval walking training by a smatrphone application
Region	Japan

Condition
Condition	Life-style related diseases
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess phsychological factors to promote habitual exercise training by using a smartphone application in middle-aged and older people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	achievement of exercise training, exercise intensity and volume during exercise training
Key secondary outcomes	body weight,physical fitness, cardiovascular regulatory capacity, blood constituents

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	a factor for self-evaluation + a factor factor for comparison with others + a factor for community production
Interventions/Control_2	a factor for self-evaluation + a factor for comparison with others
Interventions/Control_3	a factor for self evaluation + a factor for community production
Interventions/Control_4	a factor for compariso with others + a factor for community production
Interventions/Control_5	no factors
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Those who can walk independently. 2)Those who can use a smartphone. 3)Those who have given us their informed consent to participating the study.
Key exclusion criteria	1) Those who do not match the key inclusion criteria. 2) Those who a primary investigator judges to be not appropriate for participating in the study; suffeing from cardiovascular diseases and orthopedic diseases.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano Prefecture
TEL	0263-37-2682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi, Matumoto, Nagano Prefecture
TEL	2063-37-2682
Homepage URL
Email	masuki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu University
Address	3-1-1 Asahi, Matumoto, Nagano Prefecture
Tel	0263-37-2572
Email	mdrinri@shinshu-u.ac.jp

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	2020 Year 06 Month 08 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	Preinitiation
Date of protocol fixation	2020 Year 05 Month 20 Day
Date of IRB	2020 Year 05 Month 20 Day
Anticipated trial start date	2020 Year 05 Month 20 Day
Last follow-up date	2022 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	2020 Year 06 Month 05 Day
Last modified on	2020 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046412