UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020870 |
|---|---|
| Receipt number | R000023923 |
| Scientific Title | Effect of respiratory system on cardiovascular and circulatory regulations during exercise |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2022/08/10 07:47:58 |
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Basic information
Public title
Effect of respiratory system on cardiovascular and circulatory regulations during exercise
Acronym
Effect of respiratory system on cardiovascular regulations
Scientific Title
Effect of respiratory system on cardiovascular and circulatory regulations during exercise
Scientific Title:Acronym
Effect of respiratory system on cardiovascular regulations
Region
| Japan | North America |
Condition
Condition
The subjects in the present study are healthy humans. We think that respiratory muscle training would be useful for the patients with pulmonary disease and heart failure.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to clarify the effect of respiratory muscle activation on cardiovascular regulation.
Basic objectives2
Others
Basic objectives -Others
We research cardiovascular regulation system on the exercise physiology research area.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We estimate heart rate, blood pressure, and sympathetic nerve activity during an increasing and decreasing respiratory muscle activation.
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
| Other |
Interventions/Control_1
We measure respiratory, cardiovascular, and sympathetic nerve responses during voluntary hyperpnoea and exercise.
Frequency: 3-6 times/subject, Exercise intensity: 10-70%VO2max, Exercise duration: 10-15 min/time, Duration: 5 years
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women, who do not interfere with daily life.
Key exclusion criteria
Patients with respiratory and cardiovascular disease.
Target sample size
60
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 E5-2 (130), Chikusa-ku, Nagoya
TEL
052-789-5754
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 E5-2 (130), Chikusa-ku, Nagoya
TEL
052-789-5754
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of the Nagoya University Graduate School of Medicine
Address
Tsurumai65, Showa-ku, Nagoya
Tel
052-9744-2423
nagoya@esct.bvits.com
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
| 2016 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/30462876/
Number of participants that the trial has enrolled
10
Results
Healthy young men performed two bilateral knee extension and flexion exercise tests at 40% VO2peak. Arterial blood pressure and blood flow to the brachial and femoral artery were monitored. MAP during exercise was increased with inspiratory resistance. Brachial blood flow attenuated with inspiratory resistance. Femoral blood flow was maintained throughout exercise was unchanged with inspiratory resistance.
Results date posted
| 2020 | Year | 08 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Ten healthy males 20+-2 years
Participant flow
Using online recruitment system for human research at Nagoya University
Adverse events
N/A
Outcome measures
Maximal oxygen uptake, arterial blood pressure, femoral and brachial artery blood flow
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023923
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