UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029902
Receipt number R000034158
Scientific Title Development of a mobile application for remotely supervised exercise training system using IoT to increase the larger number of participants.
Date of disclosure of the study information 2017/11/09
Last modified on 2017/11/09 17:34:03

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Basic information

Public title

Development of a mobile application for remotely supervised exercise training system using IoT to increase the larger number of participants.

Acronym

Mobile aplication to increase physical fitness

Scientific Title

Development of a mobile application for remotely supervised exercise training system using IoT to increase the larger number of participants.

Scientific Title:Acronym

Mobile aplication to increase physical fitness

Region

Japan


Condition

Condition

Lifestyle related diseases

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The development of mobile application to incresae physical fitness by home-based walking training

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Traininng acjievement for 5 months, exercise intensity, energy expenditure during exercise training

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

We measure energy expenditure during walking training for 5 months with portable calorie meter and transfer the walking record to the sever computer usong PC terminal through an internet.

Interventions/Control_2

We measure energy expenditure during walking training for 5 months with moblie application and transfer the walking record to the sever computer.

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) College students (20-30 yr)
2) Workers (30-50 yr)
3) Middle-aged and older people (40-70 yr)
4) Patients suffering lifestyle related diseases
5) Frail people
6) Those who agree to paricipate in the study and giv informed consent afer face to face explanation

Key exclusion criteria

1) Those who cannnot walk
2) Those who a chief investigator judge as inappropriate to participate in the study vecause of cardiorespiratory and orthopedic diseases.

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shizue Masuki

Organization

Shinshu University

Division name

Graduate School of Medicine

Zip code


Address

3-1-1 Asahi Matsumoto, 390-8621

TEL

0263-37-2682

Email

masuki@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shizue Masuki

Organization

Shinshu University

Division name

Graduate School of Medicine

Zip code


Address

3-1-1 Asahi Matsumoto 390-8621

TEL

0263-37-2682

Homepage URL


Email

masuki@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Reserach and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 11 Month 09 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

2017 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 09 Day

Last modified on

2017 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034158


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name