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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015425
Receipt No. 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

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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
Email 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
Email d906eb@gmail.com

Sponsor
Institute Cardiovascular Division, University of Tsukuba Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017857

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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