UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043799 |
|---|---|
| Receipt number | R000049995 |
| Scientific Title | Examining the Efficacy of the Health Project, the Walking (Exercise) Course for You |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/03/31 19:21:42 |
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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
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
sakai@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049995
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
