UMIN-CTR Clinical Trial

Basic information
Public title	Does arterial stiffening with resistance training impaired arterial baroreflex sensitivity?
Acronym	arterial stiffening and arterial baroreflex sensitivity
Scientific Title	Effect of decreased central arterial compliance with resistance training on arterial barorefrex sensitivity
Scientific Title:Acronym	central arterial compliance and arterial baroreflex sensitivity
Region	Japan

Condition
Condition	healthy young men and resistance trained men
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate that effect of decreased central arterial compliance with resistance training on arterial baroreflex.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Central stiffness and compliance, arterial baroreflex sensitivity (In study 1, compared with resistance trained and non trained. In study 2, performed resistance training for 12 weeks and measured before and after trainining)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Period: 12 weeks Trial: resistance training
Interventions/Control_2	Period: 12 weeks Trial: control
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	18 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	Healthy young men
Key exclusion criteria	Subjects who are stopped exercise by doctor Subjects who have ever suffered a massive heart attack and stroke Subjects who are hypertension (140mmHg/90mmHg) Subjects who are diabetes Subjects who are Orthopedic pain Subjects who had a compression fracture before Subjects who are smoker
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Muraoka
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	04-2947-7128
Email	imuraoka@waseda.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Nakamura
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	04-2947-6833
Homepage URL
Email	nnakamura@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Ministry of education
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	Waseda University
Address	1-104 Totsuka, Shinjuku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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 09 Month 27 Day

Related information
URL releasing protocol	UMIN000038116protocol
Publication of results	Published

Result
URL related to results and publications	UMIN000038116results
Number of participants that the trial has enrolled	40
Results	Central arterial stiffness was significantly higher in the resistance-trained group than in the control group. By contrast, the arterial compliance and arterial baroreflex sensitivity (BRS) in the resistance-trained group were significantly lower than those in the control group. Moreover, a negative correlation was found between cardiovagal BRS and Central arterial stiffness. Considering these results, greater central arterial stiffness in resistance-trained men may be associated with lower cardiovagal BRS.
Results date posted	2022 Year 07 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	healthy subjects
Participant flow	informed consent confirmed training frequency performed measuring
Adverse events	No
Outcome measures	central arterial stiffness arterial baroreflex sensitivity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 07 Month 16 Day
Anticipated trial start date	2019 Year 10 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 07 Month 02 Day
Date trial data considered complete	2022 Year 07 Month 02 Day
Date analysis concluded	2022 Year 07 Month 02 Day

Other
Other related information

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2022 Year 07 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043442