UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033506 |
|---|---|
| Receipt number | R000038181 |
| Scientific Title | The effect of improvement of sarcopenia, frailty, and exercise tolerance by nutrition support for recovery phase cardiac rehabilitation. |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2020/07/31 13:17:24 |
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Basic information
Public title
The effect of improvement of sarcopenia, frailty, and exercise tolerance by nutrition support for recovery phase cardiac rehabilitation.
Acronym
The effect of nutrition support
Scientific Title
The effect of improvement of sarcopenia, frailty, and exercise tolerance by nutrition support for recovery phase cardiac rehabilitation.
Scientific Title:Acronym
The effect of nutrition support
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether nutrition support improves improves sarcopenia, frailty, and exercise tolerance during recovery phase of acrdiac rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise tolerance
Key secondary outcomes
lipid profile, BNP, NT-pro BNP, endothelial function by FMD, vascular function by PASESA and nico, physical activities, muscle volume, muscular strength, the rate of sarcopenia, frailty, and MACE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group which intakes one nutrition support drink after each cardiac rehabilitation during 3 months
Interventions/Control_2
Group which does not intake nutrition support drink
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
The patient who suffered from cardiovascular disease and has visited cardiac rehabilitation at least twice a week during recovery phase of cardiac rehabilitation and does not have an allergy of dairy product is included.
Key exclusion criteria
The patient who has an allergy of dairy product is excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Miura |
Organization
Fukuoka University
Division name
Cardiology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, FUkuoka, Japan
TEL
092-801-1011
miuras@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Suematsu |
Organization
Fukuoka University
Division name
Department of Cardiology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, FUkuoka, Japan
TEL
092-801-1011
Homepage URL
ysuematsu@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, school of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, school of Medicine, Fukuoka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
This study was cancelled the approval due to the matter for specific Institutional Review Board.
Results date posted
| 2020 | Year | 07 | Month | 31 | Day |
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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 25 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
