UMIN-CTR Clinical Trial

Basic information
Public title	effect of increase arterial stiffness by resistance training on cerebral hemodynamic
Acronym	effect of resistance training on cerebral hemodynamic
Scientific Title	effect of increase arterial stiffness by resistance training on cerebral hemodynamic
Scientific Title:Acronym	effect of resistance training on cerebral hemodynamic
Region	Japan

Condition
Condition	healthy adult men
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate whether increase arterial stiffness by resistance training on cerebral hemodynamic. Also, The purpose of this study was to examine the effect of increased central arterial stiffness and decreased arterial compliance by RT on CBF pulsatility. To investigate this purpose, we designed a cross-sectional study in which central arterial stiffness and compliance, and CBF pulsatility in resistance-trained men were compared with those in age-matched non-resistance-trained subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of increase arterial stiffness by resistance training on cerebral hemodynamic.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	Other
Interventions/Control_1	Exercise intensity was 75-80% of Repetition Mmaximal and exercise duration was 30 minutes.
Interventions/Control_2	To keep normal life
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	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male
Key inclusion criteria	healthy adult over 20 years old. The resistance-trained men had been performing vigorous RT for >2 years, >5 days/week.
Key exclusion criteria	subjects who are stopped exercise by doctor, have diabetes, have cardiovascular disease, orthopedic pain, smoking habit. None of the subjects in the sedentary group regularly engaged in RT. All the subjects were normotensive (<140/90 mmHg), and none of them ever used medications such as anabolic steroids.
Target sample size	60

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	Graduate School of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	04-2947-7128
Homepage URL
Email	nobu0902@toki.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	A Waseda University Grant
Organization
Division
Category of Funding Organization	Other
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 Totsukamachi, Shinjuku-ku, Tokyo
Tel	0352721639
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	2016 Year 08 Month 29 Day

Related information
URL releasing protocol	UMIN000023816protocol
Publication of results	Published

Result
URL related to results and publications	UMIN000023816results
Number of participants that the trial has enrolled	8
Results	high-intensity resistance exercise (HRE) led to increased arterial stiffness and decreased cerebral blood flow (CBF). Moreover, a negative correlation was observed between CBF and arterial stiffness after exercise. These results suggested that increased arterial stiffness with HRE influenced a reduction in CBF.
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	arterial stiffness cerebral blood flow
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 29 Day
Date of IRB	2016 Year 08 Month 29 Day
Anticipated trial start date	2016 Year 08 Month 29 Day
Last follow-up date	2017 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	2016 Year 08 Month 29 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=R000027436