UMIN-CTR Clinical Trial

Basic information
Public title	Effect of exercise training on exercise tolerance capacity,coronary microcirculation and adventitia in patients with vasospastic angina.
Acronym	Exercise-VSA Study
Scientific Title	Effect of exercise training on exercise tolerance capacity,coronary microcirculation and adventitia in patients with vasospastic angina.
Scientific Title:Acronym	Exercise-VSA Study
Region	Japan

Condition
Condition	Vasospastic angina
Classification by specialty	Medicine in general Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of exercise on coronary vasomotion and exercise tolerance capacity in patient with vasospastic angina.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	(1)Change of exercise tolerance capacity assessed by cardiopulmonary testing.
Key secondary outcomes	(2)Coronary perivascular adipose tissue volume and myocardial circulation. (3)General blood examination data, Rho-kinase activity. (4)Change of QOL score assessed by questionnaire

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	Behavior,custom
Interventions/Control_1	Patients with vasospastic angina are randomly assigned either to a training group or to an control group. Patients assigned to the training program are provided with a bicycle ergometer and instructed to exercise 30 minutes per day at target heart rate measured by cardiopulmonary exercise testing at home for 3 months, 3-5days per week.Target heart rate is their heart rate at anaerobic threshold.In addition, they participate in the weekly training program
Interventions/Control_2	Patients assigned to the control group don't participated in training program.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients with vasospastic angina
Key exclusion criteria	(1) Acute coronary syndrome (2) EF is under 40%. (3) Severe renal failure. (4) Severe contrast media allergy (5) history of cardiac surgery (6) Severe asthma (7) Diabetes which needs insulin therapy (8) Patients with coronary artery stenosis>75% (9) Patients suspected exercise induced vasoconstriction (10) Patients with chronic obstructive pulmonary disease
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Shimokawa
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan,
TEL	+81-22-717-7153
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Yasuharu Middle name Last name Matsumoto
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan,
TEL	+81-22-717-7153
Homepage URL
Email	matsumoto@cardio.med.tohoku.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University Hospital
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan,
Tel	+8122-728-4105
Email	rinri-2@proj.med.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	2016 Year 09 Month 09 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 08 Month 17 Day
Date of IRB	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 09 Day
Last follow-up date	2019 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	2016 Year 09 Month 09 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027624