UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034421 |
|---|---|
| Receipt number | 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 | 2023/04/12 17:41:08 |
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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
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
k2ashikaga@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-18K10763/18K10763seika/
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-18K10763/18K10763seika/
Number of participants that the trial has enrolled
13
Results
The 13 subjects were included, however, 3 subjects dropped out. A symptom-limited cardiopulmonary exercise test was performed just after discharge, and exercise prescription was given to the ET group at the anaerobic threshold. One heart failure death was observed in the NET group, but no recurrence was observed. It was suggested that ET may suppress recurrence.
Results date posted
| 2023 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age : 72 years old
Participant flow
1) After admission we explain about this study, and obtain a written informed consent before exit the intensive care unit
2) Random allocation (divide into psysical training group and non-physical training group)is done.
3) Perform usual cardiac rehabilitation on the admission term in both group.
4) Out-patient rehabilitation was performed in the physical training more than 1 time per week for 4months.
5) Exercise therapy was based on the aerobic threshold from cardiopulmonary exercise test.
Adverse events
None
Outcome measures
Recurrence of Takotsubo syndrome
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | 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
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039228
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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