UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034069 |
|---|---|
| Receipt number | R000038837 |
| Scientific Title | The relationship between peak aerobic capacity and the lower urinary tract symptoms in middle-aged and older people |
| Date of disclosure of the study information | 2018/09/10 |
| Last modified on | 2018/09/08 11:04:51 |
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Basic information
Public title
The relationship between peak aerobic capacity and the lower urinary tract symptoms in middle-aged and older people
Acronym
VO2peak and LUTS
Scientific Title
The relationship between peak aerobic capacity and the lower urinary tract symptoms in middle-aged and older people
Scientific Title:Acronym
VO2peak and LUTS
Region
| Japan |
Condition
Condition
The lower urinary tract symptoms
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the hypothesis that the morbidity of the lower urinary tract symptoms is lower in middle-aged and older people whose peak aerobic capacity is higher.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between peak aerobic capacity and the lower urinary tract symptoms
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Peak aerobic capacity measurement
Questioinnaire regarding the lower urinary tract symptoms
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Middle-aged and older people living in Matsumoto who has participated in the Health Promotion Program which has been organized by Department of Sports Medical Sciences, Shinshu University Graduate School of Medicine for these over 20 years.
2) Those who participated in the mesaurements of peak aerobic capacity and blood constituents related to life style related diseases, in April, 2018.
3) Those who answer the questinnaire regarding the lower urinary tract symptoms delivered by us.
4) Those who agree to participate in the study with providing us with a wiritten informed consent.
Key exclusion criteria
1) Those who do not participate in the Health Promotion Program.
2) Those who did not participat in the mesaurements of peak aerobic capacity and blood constituents related to life-style related diseases in April, 2018.
3) Those who do not answer the questinnaire regarding the lower urinary tract symptoms delivered by us.
4) Those who do not agree to participate in the study.
5) Those whom the primary investogator judge as irrelevant to participate in the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizue Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2681
Homepage URL
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 09 | Month | 10 | 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
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 | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038837
| 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 |
