UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038539
Receipt number R000043896
Scientific Title The physical and mental impacts by Urabandai walking
Date of disclosure of the study information 2019/11/11
Last modified on 2019/11/11 13:39:12

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Basic information

Public title

The physical and mental impacts by Urabandai walking

Acronym

Urabandai walking

Scientific Title

The physical and mental impacts by Urabandai walking

Scientific Title:Acronym

Urabandai walking

Region

Japan


Condition

Condition

Mental disorder

Classification by specialty

Psychosomatic Internal Medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the impacts of Urabandai walking program

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Salivary amylase before and after intervention

Key secondary outcomes

Profile of Mood Statss(POMS2 short version), Self Efficacy(GSES), Subjective status (Visual analog Scale) before and after intervention


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Urabandai Walking program

Interventions/Control_2


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy Adults

Key exclusion criteria

Who prohibited exercise

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hirokazu
Middle name
Last name Sabane

Organization

JTB

Division name

Sendai branch

Zip code

980-0804

Address

1-4-1 Omachi, Aobaku, Sendai city, Miyagi

TEL

022-263-6712

Email

h_sabane217@jtb.com


Public contact

Name of contact person

1st name Hirokazu
Middle name
Last name Sabane

Organization

JTB

Division name

Sendai Branch

Zip code

980-0804

Address

1-4-1 Omachi, Aobaku, Sendai city, Miyagi

TEL

022-263-6712

Homepage URL


Email

h_sabane217@jtb.com


Sponsor or person

Institute

JTB Sendai Branch

Institute

Department

Personal name



Funding Source

Organization

Kitashiobara village

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Health & Research Institute

Address

3-1-4 Nihonbashi, Chuo, Tokyo

Tel

03-5290-1621

Email

info@jph-ri.or.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

2019 Year 11 Month 11 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

2020 Year 06 Month 20 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018 Year 10 Month 10 Day

Date of IRB

2019 Year 11 Month 08 Day

Anticipated trial start date

2019 Year 11 Month 11 Day

Last follow-up date

2019 Year 11 Month 30 Day

Date of closure to data entry

2019 Year 11 Month 30 Day

Date trial data considered complete

2019 Year 11 Month 30 Day

Date analysis concluded

2020 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2019 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name