UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027355 |
|---|---|
| Receipt number | 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 | 2020/05/18 09:32:45 |
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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 | 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
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
pttoshimisato@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031347
