UMIN-CTR Clinical Trial

Basic information
Public title	Examining the Efficacy of the Health Project, the Walking (Exercise) Course for You
Acronym	Examining the Efficacy of the Health Project, the Walking (Exercise) Course for You
Scientific Title	Examining the Efficacy of the Health Project, the Walking (Exercise) Course for You
Scientific Title:Acronym	Examining the Efficacy of the Health Project, the Walking (Exercise) Course for You
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to verify the feasibility and effectiveness of the "Walking (Exercise) Course, which you had in your health project" newly planned as a plot building project of Niigata City .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait measurements (changes in gait speed, step length, up and down movements, foot upstroke, speed, balance, and posture measured by the gait analysis system)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention consisted of participating three times in a walking course that included an interview, visualization of gait posture measurement results, lectures, measurement of body indicators, and a menus of gait posture instruction.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Residents aged 20 years or older living in Niigata City and participating in the "Walking Associations in the Nishikan Region" or the "Measurement Exercise Class" who agreed to participate in this study.
Key exclusion criteria	Individuals with disease currently being treated and who do not have permission from their primary care physician. Individuals who cannot answer the questionnaire due to marked cognitive deterioration Persons using pacemakers to use body composition monitors Those who have participated in the Walking Style Course that suited you less than once Individuals who judged that the researcher was obviously in poor physical condition based on blood pressure and pulse measurement results on the day you participated in the Walking Course
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sayuri Middle name Last name Sakai
Organization	Niigata University
Division name	graduate school of health science
Zip code	9518518
Address	2-746 asahimachi-dori,chuo-ku Niigata,Japan
TEL	025-227-0941
Email	sakai@clg.niigata-u.ac.jp

Public contact
Name of contact person	1st name Sayuri Middle name Last name Sakai
Organization	Niigata University
Division name	graduate school of health science
Zip code	9518518
Address	2-746 asahimachi-dori,chuo-ku Niigata,Japan
TEL	025-227-0941
Homepage URL
Email	sakai@clg.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Niigata city
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata University IRB
Address	1-757 asahimachi-dori,chuo-ku Niigata,Japan
Tel	025-227-2625
Email	ethics@adm.niigata-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	2021 Year 03 Month 31 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	24
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	2019 Year 10 Month 15 Day
Date of IRB	2019 Year 09 Month 18 Day
Anticipated trial start date	2019 Year 10 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 31 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049995