UMIN-CTR Clinical Trial

Basic information
Public title	A study on changes in oxidative stress levels before and after whole body vibration stimulation training
Acronym	A study on changes in oxidative stress levels before and after whole body vibration stimulation training
Scientific Title	A study on changes in oxidative stress levels before and after whole body vibration stimulation training
Scientific Title:Acronym	A study on changes in oxidative stress levels before and after whole body vibration stimulation training
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Oxidative stress is an important factor in the pathophysiology of obstructive airway diseases (mainly bronchial asthma and chronic obstructive pulmonary disease). Therefore, we investigate the relationship between whole body vibration training using TOYO MEDIC Galileo and oxidative stress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Oxidative stress marker,Inflammatory cytokine
Key secondary outcomes	Respiratory function, physical activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	current smoker and never smoker
Interventions/Control_2	The subject performs squats on the whole body vibration training device for 3 days a week for 12 weeks continuously.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy adult with no age limit. 2. Written informed consent to participate in this study
Key exclusion criteria	1. Participated in other research within the last 8 weeks 2. Have respiratory illness 3. Pregnancy 4. Acute thrombosis 5. Training site implant 6. Acute inflammation of the musculoskeletal system 7. Arthrosis 8. Training site acute tendonitis 9. Acute hernia 10. Acute disc disease 11. Fresh fracture of the training site 12. Kidney stones, gallstones 13. Post-operative fresh wounds and scars at the training site 14. Rheumatoid arthritis 15. Epilepsy 16. Bone tumor 17. Acute stroke
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuhisa Middle name Last name Asai
Organization	Osaka City University Graduate School of Medicine
Division name	Respiratory Medicine
Zip code	545-8585
Address	1-4-3 Asahi-machi, Abenoku, Osaka
TEL	06-6645-3916
Email	kazuasai@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Kazuhisa Middle name Last name Asai
Organization	Osaka City University Graduate School of Medicine
Division name	Respiratory Medicine
Zip code	545-8585
Address	1-4-3 Asahi-machi, Abenoku, Osaka
TEL	06-6645-3916
Homepage URL
Email	kazuasai@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Osaka City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Medical Research Ethics Review Committee
Address	abeno-medics 6 floor,,1-2-7 asahi-machi, abenoku, osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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	大阪市立大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 22 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	2020 Year 04 Month 13 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047380