UMIN-CTR Clinical Trial

Basic information
Public title	Effect of frequency of aerobic exercise training on arterial stiffness
Acronym	Effect of frequency of aerobic exercise training on arterial stiffness
Scientific Title	Effect of frequency of aerobic exercise training on arterial stiffness
Scientific Title:Acronym	Effect of frequency of aerobic exercise training on arterial stiffness
Region	Japan

Condition
Condition	Arteriosclerosis
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The present study aimed to determine the effects of frequency of aerobic exercise training (twice or four times a week) on arterial stiffness in the middle-aged and elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pulse wave velocity (PWV), central arterial vascular index (AVI), and brachial arterial vascular index (API) will be measured in the aorta (carotid-to-femoral artery), systemic artery (brachial-to-ankle), and artery containing the proximal aorta (heart-to-brachial) before and after 8 weeks of training.
Key secondary outcomes	Brachial and ankle blood pressure (oscillometric method), heart rate (electrocardiogram), height, weight, body fat percentage, and maximal oxygen uptake (VO2max, breath-by-breath method) will be measured before and after 8 weeks of training.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Aerobic exercise training (walking, jogging) 8 weeks Moderate intensity (50-60% of the age-predicted maximum heart rate) 30 minutes/time 2 days a week
Interventions/Control_2	Aerobic exercise training (walking, jogging) 8 weeks Moderate intensity (50-60% of the age-predicted maximum heart rate) 30 minutes/time 4 days a week
Interventions/Control_3	No aerobic exercise training (walking, jogging) (control group)
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	45 years-old <=
Age-upper limit	80 years-old >=
Gender	Female
Key inclusion criteria	1) Schedule can be adjusted 2) Body mass index (BMI) is less than 18.5 to 25 kg / m2 3) You can follow the precautions when participating in the experiment 4) No smoking habits 5) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1) If you have a chronic disease 2) When the subject has severe physical symptoms and it is difficult to cooperate with the research 3) In addition, if the person in charge of the survey judges it inappropriate to participate
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Kobayashi
Organization	Teikyo University of Science
Division name	Center for Fundamental Education
Zip code	120-0045
Address	2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL	03-6910-1010
Email	rkobayashi@ntu.ac.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Kobayashi
Organization	Teikyo University of Science
Division name	Center for Fundamental Education
Zip code	120-0045
Address	2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL	03-6910-1010
Homepage URL
Email	rkobayashi@ntu.ac.jp

Sponsor
Institute	Center for Fundamental Education, Teikyo University of Science
Institute
Department

Funding Source
Organization	OG Wellness Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo University of Science
Address	2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
Tel	03-6910-1010
Email	kenkyushien@ntu.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	帝京科学大学（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 10 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	27
Results	In the twice-weekly group, cfPWV, baPWV, AVI, and blood pressure decreased and VO2max increased after 8 weeks of intervention compared with the pre-intervention period. In the twice-weekly group, cfPWV, baPWV, hbPWV, AVI, API, and blood pressure decreased and VO2max increased after 8 weeks of intervention compared with the pre-intervention period. In the control group, all indices were unchanged before and after the intervention.
Results date posted	2021 Year 10 Month 21 Day
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	2020 Year 09 Month 30 Day
Date of IRB	2021 Year 07 Month 21 Day
Anticipated trial start date	2021 Year 07 Month 21 Day
Last follow-up date	2021 Year 12 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	2020 Year 09 Month 01 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047529