UMIN-CTR Clinical Trial

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
Email	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
Email	matsunag@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

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
Email	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	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 01 Month 07 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 07 Day
Last follow-up date	2021 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	2020 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048155

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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