UMIN-CTR Clinical Trial

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
Email	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
Email	nakano-h@cvc.pref.gunma.jp

Sponsor
Institute	Gunma Prefectural Cardiovascular Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043034