UMIN-CTR Clinical Trial

Basic information
Public title	Effect of exercise on physical functions in middle-aged males
Acronym	Effect of exercise on physical functions
Scientific Title	Effect of exercise on physical functions and cardiovascular diseases risk factors in middle-aged males
Scientific Title:Acronym	Effect of exercise on physical functions and cardiovascular diseases risk factors
Region	Japan

Condition
Condition	A healthy population
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effect of exercise on physical functions and cardiovascular diseases risk factors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fatty acid binding protein 4
Key secondary outcomes	Grip strength Leg muscle strength sit and reach Vertical jump Sit-up 1mile walking time Blood pressure, high-density lipoprotein cholesterol low-density lipoprotein cholesterol triglyceride fasting blood glucose insulin

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise group
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	65 years-old >=
Gender	Male
Key inclusion criteria	1. Not restricted by a medical doctor from exercise 2. A body mass index is less than 35 3 Not participate in another clinical trial in one year 4. Can agree with contents of study
Key exclusion criteria	1. Have severe heart disease, cerebrovascular disease, and renal dysfunction 2. Medical doctor cannot agree with participation in study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Nakagaichi
Organization	National Institute of Fitness and Sports in Kanoya
Division name	Faculty of Sports and Life Science
Zip code	891-2393
Address	1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
TEL	+81-994-46-4947
Email	gaichi@nifs-k.ac.jp

Public contact
Name of contact person	1st name Shigeharu Middle name Last name Numao
Organization	National Institute of Fitness and Sports in Kanoya
Division name	Faculty of Sports and Life Science
Zip code	891-2393
Address	1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
TEL	+81-994-46-4946
Homepage URL
Email	numashige@nifs-k.ac.jp

Sponsor
Institute	National Institute of Fitness and Sports in Kanoya
Institute
Department

Funding Source
Organization	Kijo, Miyazaki, Japan
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	National Institute of Fitness and Sports in Kanoya
Address	1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
Tel	+81-994-46-4878
Email	kokusai@nifs-k.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	2019 Year 07 Month 18 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	16
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 05 Month 12 Day
Date of IRB	2019 Year 05 Month 29 Day
Anticipated trial start date	2019 Year 06 Month 24 Day
Last follow-up date	2022 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	2019 Year 07 Month 18 Day
Last modified on	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042651