UMIN-CTR Clinical Trial

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 Masahiro Middle name Last name Kohzuki
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8574
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 Toshimi Middle name Last name Sato
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8574
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	Tohoku University
Address	1-1, Seiryo-cho, Aoba-ku, Sendai
Tel	022-717-8006
Email	med-kenkyo@grp.tohoku.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	2017 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212100
Number of participants that the trial has enrolled	41
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	2017 Year 02 Month 27 Day
Date of IRB	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 03 Month 05 Day
Last follow-up date	2019 Year 12 Month 30 Day
Date of closure to data entry	2020 Year 01 Month 25 Day
Date trial data considered complete	2020 Year 01 Month 25 Day
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	2020 Year 05 Month 18 Day

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