UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038116 |
|---|---|
| Receipt number | R000043442 |
| Scientific Title | Effect of decreased central arterial compliance with resistance training on arterial barorefrex sensitivity |
| Date of disclosure of the study information | 2019/09/27 |
| Last modified on | 2022/07/02 21:07:52 |
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Basic information
Public title
Does arterial stiffening with resistance training impaired arterial baroreflex sensitivity?
Acronym
arterial stiffening and arterial baroreflex sensitivity
Scientific Title
Effect of decreased central arterial compliance with resistance training on arterial barorefrex sensitivity
Scientific Title:Acronym
central arterial compliance and arterial baroreflex sensitivity
Region
| Japan |
Condition
Condition
healthy young men and resistance trained men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate that effect of decreased central arterial compliance with resistance training on arterial baroreflex.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central stiffness and compliance, arterial baroreflex sensitivity
(In study 1, compared with resistance trained and non trained. In study 2, performed resistance training for 12 weeks and measured before and after trainining)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Period: 12 weeks
Trial: resistance training
Interventions/Control_2
Period: 12 weeks
Trial: control
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy young men
Key exclusion criteria
Subjects who are stopped exercise by doctor
Subjects who have ever suffered a massive heart attack and stroke
Subjects who are hypertension (140mmHg/90mmHg)
Subjects who are diabetes
Subjects who are Orthopedic pain
Subjects who had a compression fracture before
Subjects who are smoker
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Muraoka |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL
04-2947-7128
imuraoka@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 359-1192
TEL
04-2947-6833
Homepage URL
nnakamura@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Address
1-104 Totsuka, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 09 | Month | 27 | Day |
Related information
URL releasing protocol
UMIN000038116protocol
Publication of results
Published
Result
URL related to results and publications
UMIN000038116results
Number of participants that the trial has enrolled
40
Results
Central arterial stiffness was significantly higher in the resistance-trained group than in the control group. By contrast, the arterial compliance and arterial baroreflex sensitivity (BRS) in the resistance-trained group were significantly lower than those in the control group. Moreover, a negative correlation was found between cardiovagal BRS and Central arterial stiffness. Considering these results, greater central arterial stiffness in resistance-trained men may be associated with lower cardiovagal BRS.
Results date posted
| 2022 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy subjects
Participant flow
informed consent
confirmed training frequency
performed measuring
Adverse events
No
Outcome measures
central arterial stiffness
arterial baroreflex sensitivity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 02 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043442
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