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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034421
Receipt No. R000039228
Scientific Title Exploratory evaluation of the effectiveness of exercise therapy for patients with Takotsubo syndrome
Date of disclosure of the study information 2018/10/10
Last modified on 2019/04/10

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Basic information
Public title Exploratory evaluation of the effectiveness of exercise therapy for patients with Takotsubo syndrome
Acronym Effectiveness of exercise therapy for patients with Takotsubo syndrome
Scientific Title Exploratory evaluation of the effectiveness of exercise therapy for patients with Takotsubo syndrome
Scientific Title:Acronym Effectiveness of exercise therapy for patients with Takotsubo syndrome
Region
Japan

Condition
Condition Takotsubo syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this clinical trial is to explore the evaluation of whether exercise tolerance can be improved by incorporating exercise therapy into patients with Takotsubo Syndrome. It is also an important objective of this research to obtain basic data to know about whether it can contribute to recurrence or rehospitalization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum oxygen uptake 6 months after onset
Key secondary outcomes 1) Rehospitalization due to recurrence of Takotsubo syndrome
2) All death within the period
3) Other unexpected rehospitalization
4) Anaerobic threshold and ventilatory efficiency at 6 months after onset

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 Outpatient cardiac rehabilitation: at least once a week
Exercise therapy at home: at least twice a week
Total: 3 or more times a week

Exercise therapy: Sustained training by exercise intensity at the Anaerobic threshold level obtained by cardiopulmonary exercise test is performed for about 30 minutes

Period: After discharge, until 150 days after the onset of Takotsubo syndrome
Interventions/Control_2 Control : Regular treatment
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Takotsubo syndrome case admitted to St. Marianna University School of Medicine hospital or St. Marianna University School of Medicine Yokohama City Seibu Hospital.
2) According to the Japanese Cardiovascular Society Guidelines, cases diagnosed in the acute phase by cardiac catheterization at the time of visit.
Key exclusion criteria 1) Informed consent can not be obtained in the document.
2) Patients with acute myocarditis, pheochromocytomas, hypertrophic cardiomyopathy.
3) Patients who judged high risk of exercise therapy at the time of cardiac rehabilitation during hospitalization.
4) Patients who are difficult to continuously exercise due to daily living behavior or dementia.
5) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Akashi
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, sugao, miyamae-ku, kawasaki-city, kanagawa-prefecture
TEL +81449778111
Email yoakashi-circ@umin.ac.jp

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Ashikaga
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, sugao, miyamae-ku, kawasaki-city, kanagawa-prefecture
TEL +81449778111
Homepage URL
Email k2ashikaga@marianna-u.ac.jp

Sponsor
Institute St. Marianna University 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 St. Maryanna University School of Medicine Bioethics Committee
Address 2-16-1, sugao, miyamae-ku, kawasaki-city, kanagawa-prefecture
Tel +81449778111
Email k-sienbu.mail@marianna-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 3988
Org. issuing International ID_1 St. Maryanna University School of Medicine Bioethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 10 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
2018 Year 08 Month 14 Day
Date of IRB
2018 Year 08 Month 14 Day
Anticipated trial start date
2018 Year 09 Month 07 Day
Last follow-up date
2023 Year 03 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
2018 Year 10 Month 09 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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