UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056864 |
|---|---|
| Receipt number | R000064205 |
| Scientific Title | Acute effect characteristics of thigh squeeze hold using a pneumatic cuff on arterial stiffness in healthy adults |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2025/01/29 08:28:30 |
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Basic information
Public title
Acute effect characteristics of thigh squeeze hold using a pneumatic cuff on arterial stiffness
Acronym
Acute Effects of Squeeze Hold on AS
Scientific Title
Acute effect characteristics of thigh squeeze hold using a pneumatic cuff on arterial stiffness in healthy adults
Scientific Title:Acronym
Acute Effects of Squeeze Hold on AS
Region
| Japan |
Condition
Condition
This study targets healthy adult males and does not focus on any specific disease (no applicable ICD code).
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the characteristics of the acute effects of transient squeeze hold applied to the thigh using a pneumatic cuff on arterial stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main Outcome: Cardio-Ankle Vascular Index (CAVI)
Measurement Timing: Before the intervention (after 10 minutes of supine rest) and 10 minutes after the completion of the final intervention.
The mean coefficient of variation for CAVI measurements was reported to be 3.8% by Shirai et al. (2006), indicating high reliability.
Key secondary outcomes
heart rate and blood pressure
Measurement Timing: Before the intervention (after 10 minutes of supine rest) and 10 minutes after the completion of the final intervention.
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: Compression hold (squeeze hold) applied to the left thigh using a pneumatic cuff
Pressure: 100 mmHg, Frequency: 3 sets with a 3-minute rest between sets
Posture: Supine position
Interventions/Control_2
Intervention: Compression hold (squeeze hold) applied to the left thigh using a pneumatic cuff
Pressure: 100 mmHg, Frequency: 5 sets with a 3-minute rest between sets
Posture: Supine position
Interventions/Control_3
Intervention: Compression hold (squeeze hold) applied to the left thigh using a pneumatic cuff
Pressure: 200 mmHg, Frequency: 3 sets with a 3-minute rest between sets
Posture: Supine position
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy adults
Key exclusion criteria
Individuals with exercise habits and those with peripheral arterial, coronary artery, cerebrovascular, or lower limb orthopedic diseases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Shinomiya |
Organization
Tokushima Kensei Hospital
Division name
Rehabilitation Department
Zip code
770-8547
Address
4-9, Shimosuketo-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-622-7771
mugicha2.3.4.5@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Shinomiya |
Organization
Tokushima Kensei Hospital
Division name
Rehabilitation Department
Zip code
770-8547
Address
4-9, Shimosuketo-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-622-7771
Homepage URL
mugicha2.3.4.5@gmail.com
Sponsor or person
Institute
Tokushima Kensei Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kibi International University Ethics Review Committee
Address
Iga-cho 8, Takahashi City, Okayama Prefecture, Japan
Tel
0866-22-9454
kiu-syomu@office.jei.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 | 01 | Month | 30 | 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
10
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064205
