UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043134
Receipt number R000049243
Scientific Title Effect of exercise training on circulation
Date of disclosure of the study information 2021/02/01
Last modified on 2024/01/29 01:32:25

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Basic information

Public title

Effect of central arterial adaptation with resistance training on arterial baroreflex sensitivity

Acronym

Effect of resistance training on arterial baroreflex sensitivity

Scientific Title

Effect of exercise training on circulation

Scientific Title:Acronym

Effect of resistance training on arterial baroreflex sensitivity

Region

Japan


Condition

Condition

healthy men

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to examine the effect of central arterial adaptation with resistance training on arterial baroreflex sensitivity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

arterial stiffness
baroreflex sensitivity
barereflex set point
intraocular pressure
ocular blood flow
morning blood pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention study was conducted for 12 weeks. Subjects in the RT group performed three RT sessions per week. During each training session, the subjects performed four sets of 10 repetitions in the leg press, bench press, and bent over row, along with three sets of 10 repetitions in knee extensions, shoulder press, and arm curls at 75% of 1RM. The recovery time between each exercise and each set was 60 seconds. A strength and conditioning specialist instructed the subjects of the proper form and technique for the six exercises assigned to the subjects in the RT group

Interventions/Control_2

The subjects in the CON group were instructed to maintain their normal activity level throughout the study period.

Interventions/Control_3

Training duration: 12 weeks
Training frequency: 4 times per week
Exercise duration per session: 30~40 minutes
Exercise intensity: 50%VO2max
Exercise mode: cycle ergometer

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 men who can perform one repetition maximum measurement.

Key exclusion criteria

We exclude subjects who are stopped exercise by doctor, have diabetes, have cardiovascular disease, orthopedic pain, smoking habit, regularly engaged in resistance training, hypertensive (<140/90 mmHg).

Target sample size

40


Research contact person

Name of lead principal investigator

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

TEL

04-2947-6833

Email

nnakamura@aoni.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

TEL

04-2947-6833

Homepage URL


Email

nnakamura@aoni.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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, Research with Human Subjects in office of research ethics

Address

1-104 Totsuka, Shinjuku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2020-246

Org. issuing International ID_1

Waseda University Research with Human Subjects in office of research ethics

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 07 Month 10 Day

Date of IRB

2020 Year 10 Month 16 Day

Anticipated trial start date

2021 Year 01 Month 26 Day

Last follow-up date

2024 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

2021 Year 01 Month 26 Day

Last modified on

2024 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name