UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049205 |
|---|---|
| Receipt number | R000056040 |
| Scientific Title | Cardiopulmonary baroreflex control of circulatory regulation |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2023/10/14 09:03:18 |
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Basic information
Public title
Cardiopulmonary baroreflex control of circulatory regulation
Acronym
Circulatory regulation via cardiopulmonary baroreflex
Scientific Title
Cardiopulmonary baroreflex control of circulatory regulation
Scientific Title:Acronym
Circulatory regulation via cardiopulmonary baroreflex
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to clarify cardiopulmonary baroreflex control of circulatory regulation during exercise
Basic objectives2
Others
Basic objectives -Others
The purpose of the present study is to clarify cardiopulmonary baroreflex control of circulatory regulation during exercise: age and sex differences
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate, arterial blood pressure, muscle sympathetic nerve activity, estimated central venous pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Tilt test.
+10 degree - -10 degree. 5 min for each angle. Day 1: Explanation of the experiment. Day 2: Muscle sympathetic nerve activity measurement. Day 3: Estimated central venous pressure measurement
Interventions/Control_2
Exercise test 1.
Dynamic plantar extension and flexion exercise. 5 min, three times. Day 1: Explanation of the experiment. Day 2: Muscle sympathetic nerve activity measurement. Day 3: Estimated central venous pressure measurement
Interventions/Control_3
Exercise test 2.
Dynamic leg cycle ergometer in semirecumbent position. 5 min, three times. Day 1: Explanation of the experiment. Day 2: Muscle sympathetic nerve activity measurement. Day 3: Estimated central venous pressure measurement
Interventions/Control_4
Exercise test 3.
Dynamic knee extension and flection exercise.
5 min, three times. Day 1: Explanation of the experiment. Day 2: Muscle sympathetic nerve activity measurement. Day 3: Estimated central venous pressure measurement
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects without cardiovascular, respiratory, and orthopedics diseases
Key exclusion criteria
Patients with cardiovascular, respiratory, and orthopedics diseases
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Keisho |
| Middle name | |
| Last name | Katayama |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furocho, Chikusaku, Nagoya
TEL
0527895754
katayama@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisho |
| Middle name | |
| Last name | Katayama |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furocho, Chikusaku, Nagoya
TEL
0527895754
Homepage URL
katayama@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
Furocho, Chikusaku, Nagoya
Tel
0527895754
htc-rinri@adm.nagoya-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
| 2022 | Year | 10 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056040
