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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027355
Receipt No. R000031347
Scientific Title Effects of physical activity and physical function on changes of renal function and cognitive function in patients after acute myocardial infarction.
Date of disclosure of the study information 2017/05/16
Last modified on 2018/06/30

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Basic information
Public title Effects of physical activity and physical function on changes of renal function and cognitive function in patients after acute myocardial infarction.
Acronym Effects of physical activity on renal function and cognitive function in patients after acute myocardial infarction.
Scientific Title Effects of physical activity and physical function on changes of renal function and cognitive function in patients after acute myocardial infarction.
Scientific Title:Acronym Effects of physical activity on renal function and cognitive function in patients after acute myocardial infarction.
Region
Japan

Condition
Condition acute myocardial infarction
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate the influence of physical activity and physical function on changes of renal function and cognitive function in patients after acute myocardial infarction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes renal function
Key secondary outcomes cognitive function
physical function
Geriatric Depression
Scale-Short Version-Japanese; GDS-S-J
blood biochemical examination

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Acute myocardial infarction patients who admitted in Southern TOHOKU General Hospital or SHIN-YURIGAOKA General Hospital
2) who can be followed up at the hospital (Southern TOHOKU General Hospital or SHIN-YURIGAOKA General Hospital) for 6 months after discharge
3) with informed consent
Key exclusion criteria 1) activity of daily living is dependent
2) hemodialysis
3) complicated with other acute diseases
4) underwent invasive treatment such as surgical operation during hospitalization or follow-up
5) dementia
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Kohzuki
Organization Tohoku University
Division name Graduate School of Medicine
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7351
Email kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimi Sato
Organization Tohoku University
Division name Graduate School of Medicine
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL 024-934-5570
Homepage URL
Email pttoshimisato@gmail.com

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Not receive funds
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
2017 Year 05 Month 16 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
2017 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is observational prospective study.
We will investigate physical activity and changes of physical function, renal function and cognitive function during 6 months after acute myocardial infarction.
In addition, patient characteristics will be investigated for relevant factors.

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2018 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031347

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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