UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027781
Receipt number R000031840
Scientific Title Verification of improvement of physical activities in elderly people using active guide
Date of disclosure of the study information 2017/06/16
Last modified on 2020/06/18 12:30:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Verification of improvement of physical activities in elderly people using active guide

Acronym

Verification of improvement of physical activities in elderly people using active guide

Scientific Title

Verification of improvement of physical activities in elderly people using active guide

Scientific Title:Acronym

Verification of improvement of physical activities in elderly people using active guide

Region

Japan


Condition

Condition

physical activities

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to verify the effect of improving physical activities in elderly people using active guide.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

physical activities

Key secondary outcomes

K6


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

active guide brochure is offered.

Interventions/Control_2

active guide brochure is not offered.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Elderly people who can install active style pro for 9 days or more.

Key exclusion criteria

1 Elderly people with visceral disease and those who were receiving medical treatment at the time of the study.
2 Elderly people with mental illness and those who were receiving medical treatment at the time of the study.
3 Elderly people with severe motor impairment of the upper/lower extremities.
4 Other conditions that resulted in elderly people being considered to be ineligible by the researcher.

Target sample size

82


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name owari yutaka

Organization

Shikoku medical college

Division name

Department of Judo Therapy

Zip code


Address

62-1, Hamagoban-chou Utadu-chou, Ayauta-gun, Kagawa 769-0205, Japan

TEL

0877-41-2320

Email

owari@459.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name owari yutaka

Organization

Shikoku medical college

Division name

Department of Judo Therapy

Zip code


Address

62-1, Hamagoban-chou Utadu-chou, Ayauta-gun, Kagawa 769-0205, Japan

TEL

0877-41-2320

Homepage URL

http://www.459.ac.jp/

Email

owari@459.ac.jp


Sponsor or person

Institute

shikoku medical college

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

四国医療専門学校(香川県)


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 16 Day


Related information

URL releasing protocol

http://www.459.ac.jp/

Publication of results

Unpublished


Result

URL related to results and publications

http://www.459.ac.jp/

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

2017 Year 06 Month 09 Day

Date of IRB

2017 Year 04 Month 05 Day

Anticipated trial start date

2017 Year 06 Month 16 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 16 Day

Last modified on

2020 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name