UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041638 |
|---|---|
| Receipt number | R000047529 |
| Scientific Title | Effect of frequency of aerobic exercise training on arterial stiffness |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/10/21 10:21:17 |
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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
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
rkobayashi@ntu.ac.jp
Sponsor or person
Institute
Center for Fundamental Education, Teikyo University of Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047529
