UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051911 |
|---|---|
| Receipt number | R000059224 |
| Scientific Title | Investigation of Inference of Anaerobic Threshold Levels by Double Products Using a Non-Hypertensive Blood Pressure Measurement Wearable Device |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/02/14 12:54:37 |
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Basic information
Public title
Investigation of Inference of Anaerobic Threshold Levels by Double Products Using a Wearable Device
Acronym
Investigation of Inference of Anaerobic Threshold Levels by Double Products Using a Wearable Device
Scientific Title
Investigation of Inference of Anaerobic Threshold Levels by Double Products Using a Non-Hypertensive Blood Pressure Measurement Wearable Device
Scientific Title:Acronym
Investigation of Inference of Anaerobic Threshold Levels by Double Products Using a Non-Hypertensive Blood Pressure Measurement Wearable Device
Region
| Japan |
Condition
Condition
no
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm that the AT values obtained by CPX for healthy adults are consistent with the DPBP values obtained by the Arblet wearable device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the equivalence of exercise intensity in AT and DPBP from Arblet wearable devices during the exercise test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
cardiopulmonary exercise test with a wearable device
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
Patients with absolute contraindications to cardiopulmonary exercise test
Pregnant or possibly pregnant
Those who refused to participate in the study
Persons who are deemed by the physician to be inappropriate for participation in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | taiki |
| Middle name | |
| Last name | katsumata |
Organization
Tohoku University Graduate School of Medicine
Division name
Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7353
Homepage URL
katsumata.taiki.q4@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 08 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
