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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034069
Receipt No. 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

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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
Email 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
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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