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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043329
Receipt No. R000049431
Scientific Title The intensity of the sun salutation in live online yoga and on-site yoga: A cross-sectional study
Date of disclosure of the study information 2021/02/15
Last modified on 2021/02/15

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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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