UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050435 |
|---|---|
| Receipt number | R000056924 |
| Scientific Title | Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2023/02/27 15:34:01 |
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Basic information
Public title
Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality
Acronym
Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality
Scientific Title
Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality
Scientific Title:Acronym
Acute effects of the 4-4-8 breathing technique on autonomic function, cardio-vascular dynamics, attention, and sleep quality
Region
| Japan |
Condition
Condition
Arteriosclerosis, sleep disorders
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the acute effects of the 4-4-8 breathing technique on autonomic function, circulatory dynamics, attention, and sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 trials per participant on separate days.
1. Breathing exercises + no media equipment
2. Breathing exercises
3. Control
(1) Height, weight, body fat percentage, and body mass index will be measured.
(2) Arterial stiffness, blood pressure, heart rate, and autonomic nervous system function will be measured before and 30 and 60 minutes after the 4, 4, and 8 breathing exercises (no breathing exercises and seated rest for trial 3) for trials 1 and 2.
(3) Daily life while measuring autonomic nervous system function, body movement, and step count with a heart rate sensor. 4, 4, and 8 breathing exercises will be performed every hour until 17:00 for trials 1 and 2, and one hour before bedtime (trial 3 will not be performed).
(4) During bedtime, autonomic nervous system function, body movement, and blood pressure (at 2:00 and 4:00 a.m.) will be measured using a heart rate sensor and a wrist sphygmomanometer, respectively.
(5) In the morning of the next day, arterial stiffness, blood pressure, heart rate, autonomic nervous system function, and concentration will be measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Breathing exercises and the use of media equipment are prohibited. At least 1 day of rest. Breathing exercises. At least 1 day of inactivity. Controls
The order depends on the participant.
Interventions/Control_2
Control. At least 1 day of inactivity. Breathing exercises and use of media equipment prohibited. At least 1 day of inactivity. Breathing exercises
The order depends on the participant.
Interventions/Control_3
Breathing. At least 1 day of rest. Control. At least 1 day of inactivity. Breathing exercises and use of media equipment prohibited.
The order depends on the participant.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Able to adjust the schedule
(2) Body mass index is less than 18.5-25kg/m2
(3) Those who can follow the precautions when participating in the experiment
(4) Those who have never smoked before.
(5) Have not had any abnormalities in X-rays or doctor's examinations within the past year
(6) Those who can prove a negative PCR test for the new type of coronavirus and proof of vaccination
(7) Those who do not have any difficulties in their studies (e.g., missing classes for research)
(8) Those who can keep the research conditions (sleeping hours, etc.)
Key exclusion criteria
(1) Subjects with serious physical disabilities that make it difficult for them to cooperate in the research
(2) Subjects who are using an implanted medical device such as a pacemaker
(3) Subjects taking medication or supplements
(4) Those who have an exercise habit
(5) Those who have not undergone a medical checkup within a year
(6) Those who have not undergone a medical checkup and cannot be confirmed as normal
(7) Those who cannot be proved negative by PCR test for novel coronavirus or proof of vaccination
(8) Those who cannot comply with research conditions (sleeping hours, etc.)
(9) Other cases in which the physician determines that participation in the study is inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
rkobayashi@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
Homepage URL
rkobayashi@ntu.ac.jp
Sponsor or person
Institute
Center for Fundamental Education, Teikyo University of Science
Institute
Department
Personal name
Kobayashi
Funding Source
Organization
Center for Fundamental Education, Teikyo University 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
Teikyo University of Science
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
Tel
03-6910-1010
kenkyushien@ntu.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
| 2023 | Year | 02 | Month | 28 | 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
7
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
Terminated
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056924
