UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027910 |
|---|---|
| Receipt number | R000031914 |
| Scientific Title | Effects of self-selected and instructed breathing exercises in sitting position on cardiopulmonary function and autonomic nerves system activity |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2017/06/25 14:49:44 |
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Basic information
Public title
Effects of self-selected and instructed breathing exercises in sitting position on cardiopulmonary function and autonomic nerves system activity
Acronym
Effects of self-selected and instructed breathing exercises on cardiopulmonary function and autonomic nerves system activity
Scientific Title
Effects of self-selected and instructed breathing exercises in sitting position on cardiopulmonary function and autonomic nerves system activity
Scientific Title:Acronym
Effects of self-selected and instructed breathing exercises on cardiopulmonary function and autonomic nerves system activity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of self-selected, natural deep breathing versus instructed diaphragmatic deep breathing in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of ventilatory efficiency between quiet and deep breathing phases
Key secondary outcomes
1.Comparison of heart rate between quiet and deep breathing phases
2.Comparison of autonomic nervous system activity between quiet and deep breathing phases
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1.Natural, self-selected deep breathing
2.Instructed diaphragmatic deep breathing
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who gave informed consent
Key exclusion criteria
History of respiratory disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Yokogawa |
Organization
Kanazawa University
Division name
Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address
11-80, Kodatsuno 5, Kanazawa
TEL
076-265-2618
yokogawa@mhs.mp.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Yokogawa |
Organization
Kanazawa University
Division name
Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
Address
11-80, Kodatsuno 5, Kanazawa
TEL
076-265-2618
Homepage URL
yokogawa@mhs.mp.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Yokogawa M, et al: Effects of deep breathing methods on ventilation efficiency and autonomic nerve activity. 17th WCPT, Singapore, 2015
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 27 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 24 | Day |
Last modified on
| 2017 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031914
