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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020870
Receipt No. 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 2020/08/07

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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
Email 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
Email katayama@htc.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 10 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
2020 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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