UMIN-CTR Clinical Trial

Basic information
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
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

Objectives
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

Assessment
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)

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	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

Eligibility
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

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kohzuki
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-cho, Aoba-ku Sendai, Miyagi, Japan
TEL	022-717-7353
Email	kohzuki@med.tohoku.ac.jp

Public contact
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-cho, Aoba-ku Sendai, Miyagi, Japan
TEL	022-717-7353
Homepage URL
Email	hisakomiura@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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	Tohoku University Ethics Committee of the Graduate School of Medicine
Address	1-1, Seiryo-cho, Aoba-ku Sendai, Miyagi, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	下北沢整形外科リウマチ科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 15 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
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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 11 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2022 Year 03 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	2021 Year 02 Month 15 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049431

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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