UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015425 |
|---|---|
| Receipt number | R000017857 |
| Scientific Title | The effect of cardiac rehabilitation on relapse prevention of atrial/ventricular arrhythmia in patients treated with radiofrequency catheter ablation or cardiac implantable electronic device implantation |
| Date of disclosure of the study information | 2014/10/17 |
| Last modified on | 2019/04/17 12:35:03 |
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Basic information
Public title
The effect of cardiac rehabilitation on relapse prevention of atrial/ventricular arrhythmia in patients treated with radiofrequency catheter ablation or cardiac implantable electronic device implantation
Acronym
The effect of cardiac rehabilitation on relapse prevention of arrhythmia
Scientific Title
The effect of cardiac rehabilitation on relapse prevention of atrial/ventricular arrhythmia in patients treated with radiofrequency catheter ablation or cardiac implantable electronic device implantation
Scientific Title:Acronym
The effect of cardiac rehabilitation on relapse prevention of arrhythmia
Region
| Japan |
Condition
Condition
atrial/ventricular arrythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A part of arrhythmic patients treated with the standard therapy like anti-arrhythmic agents, radiofrequency catheter ablation (RFCA) or cardiac implantable electronic device (CEID) implantation was often afraid of the recurrence, impaired their quality of life (QOL) as a result of limiting their physical activities. Exercise training was beneficial for patients with ischemic heart disease and patients with congestive heart failure, but the effect of physical training on patients with cardiac arrhythmia was not well known. We therefore conducted a randomized control study of exercise training in patients after whether RFCA or CEID implantation if 5 months of exercise could prevent treated arrhythmia, improve patients' well-being and QOL and influence hemodynamic parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
recurrence of arrhythmia, death, admission due to cardiovascular event
Key secondary outcomes
exercise tolerance, autonomic nerve function, quality of life, BNP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects assigned to a regular exercise training group carry out 30 minutes ergometer exercises, supervised by a physiotherapist. Training intensity is set under the load at the anaerobic threshold determined by cardiopulmonary exercise testing. Total exercise duration is 1-3 times weekly for 5 months.
Interventions/Control_2
Subjects assigned to a light exercise training group is limited to the load of 0-10W in ergometer regardless of their exercise capacity, and to the duration to intervene only for a month.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing radiofrequency catheter ablation for atrial fibrillation, atrial tachycardia, and ventricular tachycardia
2) Patients implanted with ICD or CRTD
3) To have names of disease covered by National Health Insurance for cardiac rehabilitation
4) Patients who are willing to participate in a training program, and able to give informed consent to participation
Key exclusion criteria
1) Contraindication of exercise training; severe chronic heart failure, unstable angina, symptomatic aortic valve stenosis, exercise induced arrhythmia, active carditis, acute systemic disease
2) Patients who have difficulty with participation in a exercise program due to an orthopedic, or neurological, or social problem.
3) Patients who can not attend regularly to a exercise program to come from a distant area
4) When the consent is not obtained
5) Patients who anticipated not to complete a exercise proglam
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jo |
| Middle name | |
| Last name | Kato |
Organization
University of Tsukuba Hospital
Division name
Cardiovascular Division
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3900
d906eb@gmail.com
Public contact
Name of contact person
| 1st name | Jo |
| Middle name | |
| Last name | Kato |
Organization
University of Tsukuba Hospital
Division name
Cardiovascular Division
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3900
Homepage URL
d906eb@gmail.com
Sponsor or person
Institute
Cardiovascular Division, University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Division, University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
Amakubo 2-1-1, Tsukuba city
Tel
029-853-3914
t-credo.adm[@]un.tsukuba.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
| 2014 | Year | 10 | Month | 17 | 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
54
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Incomplete submission to journals
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017857
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