UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038539
Receipt No. 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

* 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 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
Institute JTB Sendai Branch
Institute
Department

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
URL(English) https://upload.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


Contact us.