UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027084 |
|---|---|
| Receipt number | R000031044 |
| Scientific Title | The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2018/10/22 09:47:53 |
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Basic information
Public title
The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Acronym
The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Scientific Title
The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Scientific Title:Acronym
The respiratory and circulation dynamics change during the belt electrode skeletal muscle electrical stimulation in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Pneumology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety of the belt electrode skeletal muscle electrical stimulation (B-SES); 1) The change of the oxygen uptake, respiratory dynamics, and circulation dynamics during B-SES. 2) The effect of maximum oxygen uptake and anaerobic threshold to those changing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory rate, SpO2, pulse, blood pressure, and oxygen uptake during the belt electrode skeletal muscle electrical stimulation.
Key secondary outcomes
The maximum oxygen uptake and anaerobic threshold.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The belt electrode skeletal muscle electrical stimulation for 20 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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
The healthy adults who are affiliated with Jobu hospital for respiratory diseases or graduate school of health sciences in Gunma university and who agreed the participation in this study.
Key exclusion criteria
1) The person who suffer from heart and respiratory disease or any other medical disease.
2) The person who has pain during exercise due to any orthopedic disease.
3) Smoker.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daigo Kato |
Organization
Jobu hospital for respiratory diseases
Division name
Department of rehabilitation
Zip code
Address
586-1 Taguchi, Maebashi, Gunma
TEL
027-232-5000
dkato.rpt@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daigo Kato |
Organization
Jobu hospital for respiratory diseases
Division name
Department of rehabilitation
Zip code
Address
586-1 Taguchi, Maebashi, Gunma
TEL
027-232-5000
Homepage URL
dkato.rpt@gmail.com
Sponsor or person
Institute
Jobu hospital for respiratory diseases
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate school of health sciences, Gunma university
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学（群馬）Gunma university
上武呼吸器科内科病院（群馬）Jobu hospital for respiratory diseases
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031044
