UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041501 |
|---|---|
| Receipt number | R000047380 |
| Scientific Title | A study on changes in oxidative stress levels before and after whole body vibration stimulation training |
| Date of disclosure of the study information | 2020/08/22 |
| Last modified on | 2020/08/21 14:37:46 |
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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
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
kazuasai@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047380
