UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between peak aerobic capacity and the lower urinary tract symptoms in middle-aged and older people
Title of the study (Brief title)	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	Shizue Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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