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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037190
Receipt No. R000042392
Scientific Title The effect of aerobic exercise related to different load patterns on endothelial function in the peripheral and carotid artery
Date of disclosure of the study information 2019/06/30
Last modified on 2019/06/27

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Basic information
Public title The effect of aerobic exercise related to different load patterns on endothelial function in the peripheral and carotid artery
Acronym The effect of aerobic exercise related to different load patterns on endothelial function in the peripheral and carotid artery
Scientific Title The effect of aerobic exercise related to different load patterns on endothelial function in the peripheral and carotid artery
Scientific Title:Acronym The effect of aerobic exercise related to different load patterns on endothelial function in the peripheral and carotid artery
Region
Japan

Condition
Condition Healthy poplation
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of high intensity interval exercise and sinusoidal load exercise on flow-mediated dilation in the Brachial artery and hypercapnia-induced shear-mediated dilation in the internal carotid artery
Basic objectives2 Others
Basic objectives -Others The aim of this study is to evaluate the effect of high intensity interval exercise and sinusoidal load exercise on flow-mediated dilation in the Brachial artery and hypercapnia-induced shear-mediated dilation in the internal carotid artery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Flow-mediated dilation in the brachial artery
・Hypercapnia-induced shear-mediated dilation in the internal carotid artery
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Trials consist of a 2-min baseline period followed by 3min of hypercapnia. Target hypercapnic levels are defined from 5 to 10mmHg above baseline end-tidal PCO2.
Diameter and mean blood velocity are measured in the internal carotid artery during hypercapnic condition using a Doppler plobe.
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
20 years-old <=
Age-upper limit
39 years-old >=
Gender Male
Key inclusion criteria Healthy adults
Key exclusion criteria Present history of cardiovascular, pulmonary or metabolic
Smoking history (past 5 years)
Body Mass Index (BMI)>=25
Anemia or Syncope followed by blood sampling
Blood Pressure at rest >=130/85mmHg or <=100/60mmHg
Fasting plasma glucose =< 70mg/dL
Taking medhications
Pain in the lower limbs
Aerobic or Anaerobic exercise over 4 times by 1 week
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Neki
Organization Sapporo Medical University
Division name Department of Physical Therapy, School of health science
Zip code 060-8556
Address W17-S1 Chuo-ku Sapporo
TEL 011-611-2111
Email neki@sapmed.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Neki
Organization Sapporo Medical University
Division name Department of Physical Therapy, School of health science
Zip code 060-8556
Address W17-S1 Chuo-ku Sapporo
TEL 011-611-2111
Homepage URL
Email neki@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
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 Sapporo Medical University Research Ethics Committe
Address W17-S1 Chuo-ku Sapporo
Tel 011-611-2111
Email rinri@sapmed.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 06 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2030 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 06 Month 27 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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