UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033349
Receipt number R000038018
Scientific Title IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty
Date of disclosure of the study information 2018/08/01
Last modified on 2020/09/01 16:16:28

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Basic information

Public title

IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty

Acronym

IoT-Based Exercise Intervention Trial

Scientific Title

IoT-Based Intervention for Changing Exercsie Behavior: Prevention of Frailty

Scientific Title:Acronym

IoT-Based Exercise Intervention Trial

Region

Japan


Condition

Condition

frailty prevention

Classification by specialty

Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of IoT-based exercisse intervention on frailty prevention

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of several fitness measures for three months

Key secondary outcomes

Transition rate from pre-frailty to non-fraility for three months


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

IoT-based exercise intervention with behavioral counseling

Interventions/Control_2

IoT-based exercise intervention without behavioral counseling

Interventions/Control_3

face-to-face based exercise intervention with behavioral counseling

Interventions/Control_4

face-to-face based exercise intervention without behavioral counseling

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

pre-frailty or frailty

Key exclusion criteria

care-need certificated person and/or person forbided from exercising by the doctor

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shuzo
Middle name
Last name Kumagai

Organization

Kyushu University

Division name

Counseling and Health Center

Zip code

816-8580

Address

6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan

TEL

092-583-7853

Email

shuzo@ihs.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Kuriya

Organization

Kyushu University

Division name

Counseling and Health Center

Zip code

816-8580

Address

6-1 Kasuga-koen, Kasuga-city, Fukuoka, Japan

TEL

092-583-7853

Homepage URL

https://iot-frail.org/

Email

AMED2018@ihs.kyushu-u.ac.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

Saga University

Address

1 Honjyo-machi, Saga-city, Japan

Tel

+81952288302

Email

kyamatsu@cc.saga-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

2018 Year 08 Month 01 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

Completed

Date of protocol fixation

2018 Year 07 Month 10 Day

Date of IRB

2018 Year 08 Month 13 Day

Anticipated trial start date

2018 Year 08 Month 15 Day

Last follow-up date

2018 Year 12 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 10 Day

Last modified on

2020 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name