UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050567 |
|---|---|
| Receipt number | R000057587 |
| Scientific Title | Local effects of home-based intermittent pneumatic compression device - an interventional study -. |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2026/02/13 12:54:16 |
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Basic information
Public title
Effects of an air massager on pressure areas - an interventional study -
Acronym
Effects of an air massager
Scientific Title
Local effects of home-based intermittent pneumatic compression device - an interventional study -.
Scientific Title:Acronym
Effects of home-based intermittent pneumatic compression device
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a home-based intermittent pneumatic compression device in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue oxygen saturation at the lower leg during intervention
Key secondary outcomes
Fatigue, T2 value by MRI, Pressure on the lower leg, SpO2 at the toe, Presence of pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implementation of a home-based intermittent pneumatic compression devices
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
(1) Participants who have pain in the lower leg or any part of the same limb
(2) Those with acute inflammatory or suppurative diseases such as arteriovenous varicose veins, dermatitis, skin infection, burns, etc. in the limb to be tested
(3) Those who have developed deep vein thrombosis of the lower legs within the past 6 months
(4) Those with a pacemaker, implantable cardioverter-defibrillator, or other metal implants in the body
(5) Those with chronic heart failure
(6) Those with peripheral neuropathy or diabetes mellitus (due to the risk of possible peripheral neuropathy caused by compression)
(7) Others whom the principal investigator deems inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Komatsu |
Organization
Juntendo University
Division name
Faculty of medicine
Zip code
113-0033
Address
2-3-15 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1937
tkomatu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Aoyagi |
Organization
Juntendo University
Division name
Juntendo Administration for Sports, Health and Medical Sciences
Zip code
113-0033
Address
2-3-15 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1937
Homepage URL
m.aoyagi.vt@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
jcrtc_operation@juntendo.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
| 2023 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2026.1725445/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2026.1725445/full
Number of participants that the trial has enrolled
59
Results
Results: The rSO2 values increased significantly from baseline across all time periods. The values in periods 2, 3, and 4 were significantly higher than those in period 1 (p < 0.001), with no significant differences observed among periods 2, 3, and 4. Moreover, the T2 values significantly decreased post-intervention (Pre: median, 39.3; Post: 37.9; p < 0.001).
Results date posted
| 2026 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 59 healthy adult volunteers (37 males and 22 females) participated in this study
Participant flow
Participants were screened based on the following exclusion criteria, and eligible individuals were enrolled in this study. The exclusion criteria were as follows: (1) individuals with lower-limb injuries or pain that could interfere with the use of IPCD; (2) those with cardiovascular, dermatologic, neurologic, or metabolic diseases (including diabetes mellitus); and (3) those with a history of deep vein thrombosis within the past 6 months, considering the risk of pressure-induced injury or thrombosis. In addition, individuals with implanted metal devices such as pacemakers, who could not safely undergo magnetic resonance imaging (MRI), were excluded. Furthermore, participants with a lower-leg subcutaneous fat thickness greater than 2 cm, as measured on axial T2-weighted MRI, were excluded because muscle oxygen saturation could not be accurately assessed under these conditions.
Adverse events
Two participants reported transient mild coldness in the toes of the right leg during IPCD intervention. Because these symptoms were tolerable and did not require discontinuation of the intervention, both participants completed the full protocol and were included in the final analyses. The symptoms resolved by the end of the intervention. Notably, no other adverse reactions were noted during or after the intervention.
Outcome measures
Tissue oxygen saturation, T2-weighted MRI, Interface pressures, Maximum lower leg circumference, Subjective fatigue level in the leg, Adverse reactions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057587
