UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042185 |
|---|---|
| Receipt number | R000048155 |
| Scientific Title | Effects of multi-cuff avascularization on physical and mental health |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2023/10/24 09:11:37 |
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Basic information
Public title
Effects of multi-cuff avascularization on physical and mental health
Acronym
Effects of multi-cuff avascularization on physical and mental health
Scientific Title
Effects of multi-cuff avascularization on physical and mental health
Scientific Title:Acronym
Effects of multi-cuff avascularization on physical and mental health
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the effects of regional and remote ischemic conditioning on physical and mental health by using healthy adult volunteers.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Regional and Remote Ischemic Conditioning
MC training
Interventions/Control_2
Simple exercise only
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
Key exclusion criteria
A person with some kind of disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Matsunaga |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
4801195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561623311
matsunag@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Matsunaga |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
4801195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561623311
Homepage URL
matsunag@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
Yazakokarimata 1-1, Nagakute, Aichi
Tel
0561623311
matsunag@aichi-med-u.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
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
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
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048155
