UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059962 |
|---|---|
| Receipt number | R000068575 |
| Scientific Title | Does the Combination of Whole-Body Vibration Stimulation and Isometric Handgrip Exercise Reduce Arterial Stiffness and the Blood Pressure Response to Exercise? - A Randomized Crossover Trial - |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/05 15:37:24 |
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Basic information
Public title
Does the Combination of Whole-Body Vibration Stimulation and Isometric Handgrip Exercise Reduce Arterial Stiffness and the Blood Pressure Response to Exercise? - A Randomized Crossover Trial -
Acronym
Does the Combination of Whole-Body Vibration Stimulation and Isometric Handgrip Exercise Reduce Arterial Stiffness and the Blood Pressure Response to Exercise? - A Randomized Crossover Trial -
Scientific Title
Does the Combination of Whole-Body Vibration Stimulation and Isometric Handgrip Exercise Reduce Arterial Stiffness and the Blood Pressure Response to Exercise? - A Randomized Crossover Trial -
Scientific Title:Acronym
Does the Combination of Whole-Body Vibration Stimulation and Isometric Handgrip Exercise Reduce Arterial Stiffness and the Blood Pressure Response to Exercise? - A Randomized Crossover Trial -
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of combining isometric handgrip exercise with whole-body vibration stimulation, in comparison with trials involving isometric handgrip exercise alone, whole-body vibration stimulation alone, and control trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial Stiffness, Exercise Blood Pressure, and Related Measures
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The Combination of Isometric Handgrip Exercise and Whole-Body Vibration Stimulation
Interventions/Control_2
Isometric Handgrip Exercise
Interventions/Control_3
Whole-Body Vibration Stimulation
Interventions/Control_4
Control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Individuals Between the Ages of 21 and 50 Years
Key exclusion criteria
Those suffering from heart failure, obliterating artery disease, chronic kidney disease, or diabetes mellitus.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Hotta |
Organization
Chubu University
Division name
College of Life and Health Sciences
Zip code
4878501
Address
Matsumoto-cho 1200, Kasugai, Aichi
TEL
0568-51-9667
horinori@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hasegawa |
Organization
Chubu University
Division name
Hotta Laboratory
Zip code
4878501
Address
Matsumoto-cho 1200, Kasugai, Aichi
TEL
0568-51-9667
Homepage URL
chubunori@gmail.com
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu 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
Chubu University
Address
Matsumoto-cho 1200, Kasugai, Aichi
Tel
0568-51-4424
info-gakuji@fsc.chubu.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
| 2025 | Year | 12 | Month | 08 | 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
16
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068575
