UMIN-CTR Clinical Trial

Public title

Investigating the effects of yoga breathing and humming vocalizations on physical and mental health and intestinal flora

Acronym

Investigating the effects of yoga breathing and humming vocalizations on physical and mental health and intestinal flora

Scientific Title

Investigating the effects of yoga breathing and humming vocalizations on physical and mental health and intestinal flora

Scientific Title:Acronym

Investigating the effects of yoga breathing and humming vocalizations on physical and mental health and intestinal flora

Region

Japan

Condition

Adult male and female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In recent years, prolonged use of smartphones and computers has led to hunched postures and straight necks, resulting in shallow breathing and an increase in physical and mental health problems such as stiff shoulders, back pain, headaches, weakened immunity, depression and anxiety. With the goal of improving the quality of posture and breathing for many people and helping them lead healthier lives, both mentally and physically, he began researching yoga breathing and humming vocalization techniques in 2020 and developed a unique program called Sync Yoga.In a measurement study of 21 subjects conducted in late 2021, when the subjects were asked to practice nasal breathing with humming for 5 minutes, they found that there was a difference in the effect on the autonomic nervous system depending on whether they were proficient in the breathing technique or not (Presented at the Music and Acoustics Research Meeting of the Acoustical Society of Japan, February 2022). Focusing on that fact that the vagus nerve, a parasympathetic nerve, is connected from the brain to the intestines, the present study will randomly divide about 60 subjects into three groups and measure their posture and breathing conditions, examine and analyze their intestinal flora, and conduct dietary and psychological tests to investigate the relationship between yoga breathing techniques and humming vocalization techniques and intestinal flora.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Posture: Measurements of interphalangeal distance, thoracic spine rotation range of motion, change in thoracic circumference during respiration, subthoracic angle, cervical spine flexion and extension range of motion, and scapula pronation and retraction range of motion
Respiration: measurement of BOLT score
Psychological testing (WHO QOL 26)

Key secondary outcomes

Intestinal flora, dietary survey (BDHQ)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Group A (examination of intestinal flora, dietary survey, psychological test, Sync Yoga program)

(1)Attendance at online video seminars (8 x 15 minutes)
In order to learn about exercise physiology and anatomy related to breathing, subjects will attend a total of 8 video seminars between August 26 and November 19 at a time of their choice. The first video session will be held from August 26 to August 31.
The topics include "Breathing Mechanism and Body Movements," "Relationship between Normal Posture and Breathing," "Breathing Movements Guided by Yoga," etc.


(2)Participation in individual online sessions (15 minutes x 8 sessions)
Subjects assigned to Group A will be targeted. Participants will participate in a total of 8 sessions twice a month between August 26 and November 19. The schedule will be determined in coordination with the subjects.


(3)Practice breathing exercises (5 minutes per day)
Subjects assigned to group A will be targeted. Subjects will be asked to perform breathing exercises based on yoga, accompanied by humming to activate the vagus nerve. The exercise will be performed daily for 5 minutes from August 26 to November 19.

Interventions/Control_2

Group B (examination of intestinal flora, dietary survey, psychological test, Sync Yoga and stretching of the same METs)

Stretching (5 minutes per day)
Subjects assigned to group B will be targeted. For the purpose of comparison, subjects will be asked to perform the same METs of stretching as the breathing exercises in group A. The subjects will be asked to perform the exercises for 5 minutes daily between August 26 and November 19.

Interventions/Control_3

Group C (examination of intestinal flora, dietary survey, psychological test)
Group C did not involve any intervention.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Men and women who are at least 18 years of age and who are engaged in daily employment
(2) Those who can cooperate in collecting fecal samples and providing them as specimens
(3) Those who can respond to the paper-based dietary survey
(4) Those who can respond to the online psychological testing
(5) Those who can perform the breathing and posture improvement exercises specified by the institute.

Key exclusion criteria

(1) Students who are not employed on a daily basis
(2) Those requiring continuous medical treatment

Target sample size

60

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Yamamoto

Organization

Nazuna Music Inc.

Division name

Sync Yoga Laboratory

Zip code

141-0022

Address

5-24-12, Higashigotanda, Shinagawa-ku, Tokyo, Japan

TEL

050-3091-4007

Email

info@syncyoga.jp

Name of contact person

1st name	Saki
Middle name
Last name	Kamimura

Organization

Nazuna Music Inc.

Division name

Sync Yoga Laboratory

Zip code

141-0022

Address

5-24-12, Higashigotanda, Shinagawa-ku, Tokyo, Japan

TEL

050-3091-4007

Homepage URL

Email

info@syncyoga.jp

Institute

Nazuna Music Inc.

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Asahi Quality & Innovations, Ltd.

Name of secondary funder(s)

Organization

Shiba Palace Clinic Ethics Review Committee

Address

DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN

Tel

03-5408-1599

Email

jimukyoku@mail.souken-r.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2024

Year

07

Month

31

Day

Date of IRB

2024

Year

07

Month

11

Day

Anticipated trial start date

2024

Year

08

Month

14

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 related information

Registered date

2024

Year

08

Month

10

Day

Last modified on

2024

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=R000063074