UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043960 |
|---|---|
| Receipt number | R000050209 |
| Scientific Title | Safety and effectiveness of hybrid exercise that loads ergo bicycle exercise with systemic electrical stimulation |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2023/04/20 09:47:51 |
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Basic information
Public title
Safety and effectiveness of hybrid exercise that loads ergo bicycle exercise with systemic electrical stimulation
Acronym
Safety and effectiveness of hybrid exercise that loads ergo bicycle exercise with systemic electrical stimulation
Scientific Title
Safety and effectiveness of hybrid exercise that loads ergo bicycle exercise with systemic electrical stimulation
Scientific Title:Acronym
Safety and effectiveness of hybrid exercise that loads ergo bicycle exercise with systemic electrical stimulation
Region
| Japan |
Condition
Condition
Healthy person over 20 years old
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of the combination of Whole-Body Neuromusucular Electrical Stimulation (WB-NMES) and maximum load exercise on an ergocycle on hemodynamics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood fluidity at rest, immediately after maximum load, and 20 minutes later
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A cardiopulmonary exercise test will be conducted only for the ergo bicycle, and a week later, a cardiopulmonary exercise test will be conducted while simultaneously performing the ergo bicycle and electrical stimulation.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person over 20 years old
Key exclusion criteria
subjects who had implanted cardiac pacemaker
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ochiai |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Rehabilitation
Zip code
321-2593
Address
632 Takatoku Nikko, Tochigi
TEL
0288-76-1515
kyao2115@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ochiai |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Rehabilitation
Zip code
321-2593
Address
632 Takatoku Nikko, Tochigi
TEL
0288761515
Homepage URL
kyao2115@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University Nikko Medical Center
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
Dokkyo Medical University Nikko Medical Center
Address
632 Takatoku Nikko, Tochigi
Tel
0288761515
kyao2115@dokkyomed.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 01 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050209
