UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040664
Receipt number 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 15:17:16

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.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