UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024365 |
|---|---|
| Receipt number | R000027936 |
| Scientific Title | Effects of cardiac rehabilitation in the patients with heart failure -Changing of Muscle mass with exercise- |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2022/10/17 18:17:12 |
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Basic information
Public title
Effects of cardiac rehabilitation in the patients with heart failure -Changing of Muscle mass with exercise-
Acronym
Effects of cardiac rehabilitation for skeletal muscle
Scientific Title
Effects of cardiac rehabilitation in the patients with heart failure -Changing of Muscle mass with exercise-
Scientific Title:Acronym
Effects of cardiac rehabilitation for skeletal muscle
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of cardiac rehabilitation for skeletal muscle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the skeletal muscle in cardiac rehabilitation with heart failure patients.
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
Patients with chronic heart failure in Kansai Medical University Health Science Center from April 2013 to March 2018.
1.LVEF<50%,NTpro-BNP>=400pg/ml
2.Independent living
3.Cardiac rehabilitation was started before 2017/9.
Key exclusion criteria
1.Patients with serious heart failure,arrhythmia,respiratory failure,metabolic diseases.
2.Patients who has underlying disease which is serious,untreated and insufficient treatment.
3.Minor and no competent individual.
4.Patients who rejected this study.
5.Patients whom principal investigators and the research supervisor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kimura |
Organization
Kansai Medical University Hospital
Division name
Health Science
Zip code
5731191
Address
2-3-1 Shinmachi Hirakata city Osaka Japan
TEL
0728040101
kimuray@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kurose |
Organization
Kansai Medical University
Division name
Health Science
Zip code
5731010
Address
2-5-1 Shinmachi Hirakata city Osaka Japan
TEL
0728040101
Homepage URL
tsutsumi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Research Ethics Review Committee of Kansai Medical University
Address
2-5-1-701 Shinmachi Hirakata city Osaka Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
| 2016 | Year | 10 | 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
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027936
