UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037732 |
|---|---|
| Receipt number | R000043034 |
| Scientific Title | Exercise and amino acid combined therapy in patients with cardiovascular disease |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2021/02/17 12:37:43 |
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Basic information
Public title
Exercise and amino acid combined therapy in patients with cardiovascular disease
Acronym
Ex-Amino study
Scientific Title
Exercise and amino acid combined therapy in patients with cardiovascular disease
Scientific Title:Acronym
Ex-Amino study
Region
| Japan |
Condition
Condition
patients with cardiovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the rehabilitation effect of cardiac rehabilitation and amino acid preparations for patients with cardiovascular disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak VO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients in the amino acid preparation group take 5000mg of amino acid adding on exercise therapy during 150 days.
Interventions/Control_2
Patients in non-amino acid group take only exercise therapy during 150 days.
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
The outpatients who have been diagnosed with cardiovascular disease and are enrolled cardiac rehabilitation program.
Key exclusion criteria
1.Patients whose doctors banned amino acid preparations
2.Patients whose doctor decided to cancel during the study
3.Patients who have difficulty in continuing to participate in cardiac rehabilitation
4.Patients who have had no more than 2 cancels in cardiac rehabilitation
5.Patients who have difficulty participating in outpatient rehabilitation more than twice a week
6.Patients with dysphagia who have difficulty taking amino acid preparations
7.Patients who have not given consent to participate in the study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Harue |
| Middle name | |
| Last name | Nakano |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Rehabilitation Division
Zip code
371-0004
Address
3-12 Ko, Kamezumimachi, Maebashi, Gunma, Japan
TEL
027-269-7455
nakano-h@cvc.pref.gunma.jp
Public contact
Name of contact person
| 1st name | Harue |
| Middle name | |
| Last name | Nakano |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Rehabilitation Division
Zip code
371-0004
Address
3-12 Ko, Kamezumimachi, Maebashi, Gunma, Japan
TEL
027-269-7455
Homepage URL
nakano-h@cvc.pref.gunma.jp
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Gunma Prefectural Research fund
Clinico Co., Ltd.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Prefectural Cardiovascular Center
Address
3-12 Ko, Kamezumimachi, Maebashi, Gunma, Japan
Tel
027-269-7455
nakano-h@cvc.pref.gunma.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
| 2019 | Year | 08 | Month | 20 | 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
20
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
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043034
