UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052897 |
|---|---|
| Receipt number | R000060340 |
| Scientific Title | A Randomized Crossover Trial Comparing Lower Limb Negative Pressure Loading with Gravitational Loading in Healthy Subjects |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/24 19:18:43 |
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Basic information
Public title
A Randomized Crossover Trial Comparing Lower Limb Negative Pressure Loading with Gravitational Loading in Healthy Subjects
Acronym
Efficacy Trial of a Lower Limb Negative Pressure Loading Device
Scientific Title
A Randomized Crossover Trial Comparing Lower Limb Negative Pressure Loading with Gravitational Loading in Healthy Subjects
Scientific Title:Acronym
Efficacy Trial of a Lower Limb Negative Pressure Loading Device
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the Efficacy and Safety of Our Newly Developed Clinical Lower Limb Negative Pressure Loading Device Compared to Gravitational Loading.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Stroke Volume
Key secondary outcomes
Heart Rate, Systolic/Diastolic Blood Pressure, Total Peripheral Resistance, Parasympathetic Nervous Activity, Lower Limb Muscle Blood Flow, Lower Limb Skin Blood Flow, Earlobe Blood Flow
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
5
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Sitting Test: Transitioning from a supine position to a sitting position (10 minutes rest, 5 minutes sitting)
Interventions/Control_2
Standing Test: Transitioning from a supine position to a passive upright position using a head-up tilt table (10 minutes rest, 5 minutes standing)
Interventions/Control_3
Low-Intensity Lower Limb Negative Pressure Loading Test (10 minutes rest, 5 minutes LLNP)
Interventions/Control_4
Moderate-Intensity Lower Limb Negative Pressure (LLNP) Loading Test (10 minutes rest, 5 minutes LLNP)
Interventions/Control_5
High-Intensity Lower Limb Negative Pressure Loading Test (10 minutes rest, 5 minutes LLNP)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals with blood pressure within the normal range at rest
Key exclusion criteria
(1) Individuals who have experienced symptoms such as dizziness or nausea associated with orthostatic hypotension in the past 6 months.
(2) Individuals with arrhythmia.
(3) Individuals taking cardiovascular drugs that affect blood pressure, heart rate, or autonomic nervous activity.
(4) Women who are pregnant, may be pregnant, or are breastfeeding.
(5) Others whom the person in charge of this trial deems inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Hirabayashi |
Organization
Kobe University Hospital
Division name
Division of Rehabilitation Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6494
hirabayashi@phoenix.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Hirabayashi |
Organization
Kobe University Hospital
Division name
Division of Rehabilitation Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6494
Homepage URL
hirabayashi@phoenix.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
Clinical and Translational Research Center, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
kainyu@med.kobe-u.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 | 11 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | 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
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
