UMIN-CTR Clinical Trial

Public title

The exercise intensity of the sun salutation in live remote instruction yoga and on-site yoga: A cross-sectional study

Acronym

The exercise intensity of the sun salutation in live remote instruction yoga and on-site yoga

Scientific Title

The intensity of the sun salutation in live online yoga and on-site yoga: A cross-sectional study

Scientific Title:Acronym

The intensity of the sun salutation in live online yoga and on-site yoga: A cross-sectional study

Region

Japan

Condition

- Patients requiring for exercise therapy
- Patients requiring moderate intensity physical activities for exercise therapy
- Non alcoholic fatty liver disease

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examine whether the exercise intensity of live remote instruction yoga (live online yoga) is equivalent to the exercise intensity of on-site yoga and verify whether proficiency is involved in both interventions

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Metabolic equivalents (METs) calculated using oxygen uptake obtained by metabolic gas analyzer during live online yoga and on-site yoga

Key secondary outcomes

- Minute ventilation; VE
- Respiratory rate; RR
- Volume of oxygen consumed per minute; VO2
- Volume of carbon dioxide per minute; VCO2
- Energy expenditure; EE
- Heart rate
- Blood pressure
- Estimated maximum oxygen consumption; estimated VO2max
- Percentage of maximum heart rate during onsite yoga and live online yoga; %MHR
- Rating of perceived exertion (Borg scale)
- Pain measuring (NRS)
- Safety of live online yoga
- Physical activity enjoyment scale (PACES)
- Test of flexibility (Sit and reach test)

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

-Live online yoga (10minutes)
-On-site yoga (10minutes)
-Step test (up to 5 minutes)

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

- Adult men and women over 20 years old (at the time of registration)
- Healthy yoga instructors who have been practicing yoga regularly for more than 6 years.
- Healthy people who do not practice yoga regularly
- Those who can operate a personal computer alone

Key exclusion criteria

- Persons with diseases that may affect metabolic function or physical activity
- Renal dysfunction
- Decompensated cirrhosis
- Hypertension (160 or higher/100mmHg)
- Respiratory disease
- Cardiovascular disease
- Cerebrovascular disease
- Skeletal muscle disorder
- Orthopedic disease
- Women who are pregnant, may become pregnant, or fall within 28days after giving birth
- Those who refused to participate in this exam
- Persons who the doctor deems inappropriate for participation in the research
- Persons who must wear glasses

Target sample size

24

Name of lead principal investigator

1st name	Satoru
Middle name
Last name	Ebihara

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science Disability Science

Zip code

980-8574

Address

1-1, Seiryo-machi, Aoba-ku Sendai, Miyagi, Japan

TEL

022-717-7353

Email

satoru.ebihara.c4@tohoku.ac.jp

Name of contact person

1st name	Hisako
Middle name
Last name	Miura

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Internal Medicine and Rehabilitation Science Disability Science

Zip code

980-8574

Address

1-1, Seiryo-machi, Aoba-ku Sendai, Miyagi, Japan

TEL

022-717-7353

Homepage URL

Email

hisakomiura@med.tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tohoku University Ethics Committee of the Graduate School of Medicine

Address

1-1, Seiryo-machi, Aoba-ku Sendai, Miyagi, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学医学部（宮城県）

Date of disclosure of the study information

2021

Year

02

Month

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/37244081/

Number of participants that the trial has enrolled

22

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

Main results already published

Date of protocol fixation

2021

Year

02

Month

11

Day

Date of IRB

2021

Year

02

Month

26

Day

Anticipated trial start date

2021

Year

02

Month

15

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 related information

Registered date

2021

Year

02

Month

15

Day

Last modified on

2023

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049431