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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040664
Receipt No. R000046412
Scientific Title The development of a smartphone application to acelerate the adherence to interval walking training
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/05

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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