UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043134 |
|---|---|
| Receipt number | R000049243 |
| Scientific Title | Effect of exercise training on circulation |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/07/30 12:08:13 |
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Basic information
Public title
Effect of central arterial adaptation with resistance training on arterial baroreflex sensitivity
Acronym
Effect of resistance training on arterial baroreflex sensitivity
Scientific Title
Effect of exercise training on circulation
Scientific Title:Acronym
Effect of resistance training on arterial baroreflex sensitivity
Region
| Japan |
Condition
Condition
healthy men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effect of central arterial adaptation with resistance training on arterial baroreflex sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
arterial stiffness
baroreflex sensitivity
barereflex set point
intraocular pressure
ocular blood flow
morning blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention study was conducted for 12 weeks. Subjects in the RT group performed three RT sessions per week. During each training session, the subjects performed four sets of 10 repetitions in the leg press, bench press, and bent over row, along with three sets of 10 repetitions in knee extensions, shoulder press, and arm curls at 75% of 1RM. The recovery time between each exercise and each set was 60 seconds. A strength and conditioning specialist instructed the subjects of the proper form and technique for the six exercises assigned to the subjects in the RT group
Interventions/Control_2
The subjects in the CON group were instructed to maintain their normal activity level throughout the study period.
Interventions/Control_3
Training duration: 12 weeks
Training frequency: 4 times per week
Exercise duration per session: 30~40 minutes
Exercise intensity: 50%VO2max
Exercise mode: cycle ergometer
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 men who can perform one repetition maximum measurement.
Key exclusion criteria
We exclude subjects who are stopped exercise by doctor, have diabetes, have cardiovascular disease, orthopedic pain, smoking habit, regularly engaged in resistance training, hypertensive (<140/90 mmHg).
Target sample size
40
Research contact person
Name of lead principal investigator
| 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
TEL
04-2947-6833
nnakamura@aoni.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
TEL
04-2947-6833
Homepage URL
nnakamura@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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, Research with Human Subjects in office of research ethics
Address
1-104 Totsuka, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-246
Org. issuing International ID_1
Waseda University Research with Human Subjects in office of research ethics
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049243
