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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021908
Receipt No. R000025270
Scientific Title Prolonged clinical research for cardiac rehabilitation system in Gifu, Japan
Date of disclosure of the study information 2016/04/15
Last modified on 2016/04/15

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Basic information
Public title Prolonged clinical research for cardiac rehabilitation system in Gifu, Japan
Acronym Prolonged clinical research for cardiac rehabilitation system in Gifu, Japan
Scientific Title Prolonged clinical research for cardiac rehabilitation system in Gifu, Japan
Scientific Title:Acronym Prolonged clinical research for cardiac rehabilitation system in Gifu, Japan
Region
Japan

Condition
Condition Patients enrolled in cardiac rehabilitation
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Investigation for patients enrolled in cardiac rehabilitation after discharge and analysis of the effects of cardiac rehabilitation system in community-based cooperation
Basic objectives2 Others
Basic objectives -Others Investigation for the risk factors developing heart failure after myocardial infarction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Physical fitness and disease management state
2. Operation performance of cardiac rehabilitation system in community-based cooperation
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) patients enrolled in cardiac rehabilitation
2) patients form whom we obtained informed consent
Key exclusion criteria 1)patients unable to perform cardiopulmonary exercise testing
2)patients with low cognitive function (i.e., Mini Mental State Examination score < = 20 points)
Target sample size 800

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinya Minatoguchi
Organization Gifu University Hospital
Division name second department of internal medicine
Zip code
Address 1-1 Yanagido, Gifu City 501-1194, JAPAN
TEL 058-230-6000
Email anteng@gifu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takahiro Ando
Organization Gifu University Hospital
Division name department of rehabilitation
Zip code
Address 1-1 Yanagido, Gifu City 501-1194, JAPAN
TEL 058-230-6000
Homepage URL
Email anteng@gifu-u.ac.jp

Sponsor
Institute Gifu University Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2016 Year 04 Month 15 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ongoing

Management information
Registered date
2016 Year 04 Month 14 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025270

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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