UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056695 |
|---|---|
| Receipt number | R000064806 |
| Scientific Title | Association between hemodynamic responses to head-up tilt and graded exercise tests in healthy young adults |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2025/01/12 20:50:37 |
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Basic information
Public title
Relationship between hemodynamic responses to standing up and exercise in healthy adults
Acronym
Relationship between hemodynamic responses to standing up and exercise in healthy adults
Scientific Title
Association between hemodynamic responses to head-up tilt and graded exercise tests in healthy young adults
Scientific Title:Acronym
Association between hemodynamic responses to head-up tilt and graded exercise tests in healthy young adults
Region
| Japan |
Condition
Condition
Healthy Young Adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether hemodynamic responses to a head-up tilt test are associated with hemodynamic changes during and after a graded exercise test in healthy young adults.
Basic objectives2
Others
Basic objectives -Others
This study experimentally investigates whether the susceptibility to blood pressure decreases and heart rate increases during head-up tilt testing correlates with the susceptibility to blood pressure and heart rate increases during graded exercise testing, as well as the susceptibility to blood pressure and heart rate decreases following graded exercise testing.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic blood pressure change during graded exercise testing
Key secondary outcomes
Hemodynamic chnages during the head-up tilt test
-Change in systolic blood pressure
-Chnage in diastolic blood pressure
-Change in heart rate
Hemodynamic changes during the graded exercise test
-Change in diastolic blood pressure
-Change in heart rate
-Change in oxygen consumption
-Change in oxygen pulse
-Change in minute ventilation
-Change in respiratory rate
-Change in tidal volume
-Change in respiratory exchange ratio
-Change in Borg Scale
-Oxygen consumption at ventiratory threshold
Hemodynamic changes after the graded exercise test
-Change in systolic blood pressure
-Change in diastolic blood pressure
-Change in heart rate
-Change in oxygen consumption
-Change in oxygen pulse
-Change in minute ventilation
-Change in respiratory rate
-Change in tidal volume
-Change in Borg Scale
Characteristics of participants
-Sex
-Age
-Height
-Weight
-Body mass index
-Skeletal muscle mass index
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. No underlying medical conditions currently under treatment
2. Able to understand the study protocol and provide informed consent
Key exclusion criteria
1. Unable to perform orthostatic testing and exercise testing due to limited range of joint motion, pain, or unstable medical conditions
2. Unable to attach blood pressure cuff due to upper arm injury
3. Possibility of pregnancy
4. Blood pressure measured in a seated resting position meets hypertension criteria (systolic blood pressure at least 140 mmHg or diastolic blood pressure at least 90 mmHg)
5. Presence of subjective symptoms at rest including shortness of breath, chest pain, or general discomfort
6. Having metallic implants due to fractures or other conditions
7. Deemed unsuitable for participation by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
k_oyake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Oyake |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2408
Homepage URL
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Kazuaki Oyake
Funding Source
Organization
Sefl-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
信州大学（長野県）、東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 13 | 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
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study examines whether blood pressure and heart rate responses during head-up tilt testing correlate with changes in blood pressure, heart rate, respiratory data, and rate of perceived exertion during and after incremental exercise testing. In addition to univariate analysis, multivariate analysis will be conducted with adjustment for the characteristics of participants (age, sex, height, weight, body mass index, and skeletal muscle mass index).
Management information
Registered date
| 2025 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064806
