UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061016 |
|---|---|
| Receipt number | R000069811 |
| Scientific Title | Effects of Different Exercise Volume on Vascular Endothelial Function During Low-load Resistance Exercise: A Randomized Crossover Study |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/23 11:53:51 |
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Basic information
Public title
Effects of Different Exercise Volume on Vascular Endothelial Function During Low-load Resistance Exercise
Acronym
Resistance Exercise and Vascular Function
Scientific Title
Effects of Different Exercise Volume on Vascular Endothelial Function During Low-load Resistance Exercise: A Randomized Crossover Study
Scientific Title:Acronym
Low-intensity Resistance Exercise and Vascular Endothelial Function
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Different Exercise Volume on Vascular Endothelial Function During Low-load Resistance Exercise
Basic objectives2
Others
Basic objectives -Others
Investigation of the Effects of Resistance Exercise on Vascular Function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate and compare vascular function after resistance exercise with different numbers of repetitions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Behavior,custom |
Interventions/Control_1
A single session of low-volume resistance exercise
Interventions/Control_2
A single session of high-volume resistance exercise
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men
Key exclusion criteria
History of cardiovascular disease, metabolic disease, or other serious medical conditions
Current smoking habit
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kikuchi |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
045-530-5861
n.kikuchi@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Kamiya |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-0992
Homepage URL
kamiya.m@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Nippon Sport Science University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0931
kamiya.m@nittai.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
16
Results
Low-load high-effort resistance exercise was used to examine the acute effects of different exercise volumes (Failure and VL20) on vascular endothelial function. Sixteen healthy young men completed both conditions in a randomized crossover design. FMD increased after exercise with no differences between protocols. Blood lactate increased and was greater in the Failure protocol. Oxidative stress markers (d-ROMs) and antioxidant potential (BAP) increased after exercise.
Results date posted
| 2026 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixteen healthy male university students participated in this study. The mean age was 23.1 +/- 3.8 years, height was 170.6 +/- 6.0 cm, body weight was 68.9 +/- 11.3 kg, and body mass index was 23.6 +/- 3.4 kg/m2. All participants were non-smokers and had no history of hypertension or cardiovascular disease. All participants provided written informed consent before participation. All participants completed both experimental conditions and were included in the final analysis.
Participant flow
Sixteen healthy male university students were recruited and enrolled in this study. Participants were randomly assigned to the order of two exercise protocols (Failure and VL20) in a randomized crossover design. All participants completed both experimental conditions and were included in the final analysis. No participants withdrew or were excluded during the study period.
Adverse events
No serious adverse events or exercise-related adverse events were reported during the study period. All participants completed both exercise protocols safely.
Outcome measures
The primary outcome measure was vascular endothelial function assessed by flow-mediated dilation (FMD). Secondary outcome measures included resting brachial artery diameter, blood lactate concentration, blood pressure (systolic and diastolic), oxidative stress markers (d-ROMs), antioxidant potential (BAP), and the d-ROMs/BAP ratio. Measurements were performed before and after exercise.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069811
