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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041638 |
Receipt No. | 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 | 2020/09/01 |
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 |
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Condition | |||
Condition | Arteriosclerosis | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The present study aimed to determine the effects of frequency of aerobic exercise training 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 | Aorta (carotid-femoral) and systemic arteries (brachial-ankle) pulse wave velocity (PWV) is measured before training, 4 and 8 weeks after training. From the above, the change in PWV is evaluated. |
Key secondary outcomes | Brachial and ankle blood pressure (oscillometric method), heart rate (ECG), height, weight, body fat percentage, and peak oxygen uptake is measured before training, 4 and 8 weeks after training. From the above, changes in Brachial and ankle blood pressure, heart rate, height, weight, body fat percentage, and peak oxygen uptake are evaluated. |
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 | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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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 |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and 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. |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047529 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |