This randomized Clinical study is going to be done in Tehran Heart Center. Patients with chronic atrial fibrillation with NYHA FC II or more who live in Tehran participate in this study. The patiens do not have significant differences with each other in echocardographic findings or past medical history. Patients who have containdications for exercise are excluded. At first,candidate patients perform 12-ECG, echocardiography & exercise test. 50% of patients randomly devide into 2 groups (CR & control) according to Balanced Block Randomization method. The rest of the patients are devided according to the analysis of the results of different parameters. In CR group,patiens participate in cardiac rehabilitation program for 1 month, but in control group,patients are not to be intervened except general advices for patiens with cardiac disease. At the end of the study, the mentioned tests are done again for all of the patients.
Rehabilitation protocol used for CR group in Heart Center consists of 12 sessions during 4 weeks (3 times each week). Each session includes of three 20-min period of warm-up, cardiac re-education and cool-down.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102315128N1
Registration date:2014-09-08, 1393/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Fatemeh Khodadadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 2745
Email address
f-khodadadi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Exercise – Based Cardiac Rehabilitation on control of rhythm and Quality life in patients with chronic Atrial fibrillation
Public title
The effect of Cardiac Rehabilitation in making a better life for patients with Atrial Fibrillation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Patients with chronic atrial fibrillation ; with NYHA FC II or more; not having significant differences with other patients in past medical history and echocardiographic findings; patients who live in Tehran.
Exclusion criteria:Patients with chronic atrial fibrillation who have contraindications for exercise.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics and History of Medicine Research Center of Tehran University of Medical Sciences
Street address
No. 23,4th Floor, before Pour Sina St., 16th Azar St. , Keshavarz Blvd. Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2013-10-13, 1392/07/21
Ethics committee reference number
92-01-149-18944-95130
Health conditions studied
1
Description of health condition studied
atrial fibrillation
ICD-10 code
I48
ICD-10 code description
فیبریلاسیون و فلاتر دهلیزی
Primary outcomes
1
Description
number of heart rate
Timepoint
before intervention-after intervention
Method of measurement
number of heart rate in one minute
2
Description
Quality of life
Timepoint
before intervention-after intervention
Method of measurement
SF-36 Questionnaire
Secondary outcomes
1
Description
physical activity measure
Timepoint
befor intervention-after intervention
Method of measurement
IOAQ questionnaire
2
Description
having depression or not
Timepoint
before intervention
Method of measurement
Beck test
Intervention groups
1
Description
Rehabilitation protocol used for CR group in Heart Center consists of 12 sessions during 4 weeks(3 times each week).Each session includes of three 20-min period of warm_up,cardiac re-education,and cool_down.
Category
Rehabilitation
2
Description
In control group,patients are not to be intervened except general advices for patiens with cardiac disease.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Fatemeh khodadadi
Street address
karegare shomali avenue, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shaahin akhoondzadeh
Street address
No 206, Flat 1, Building no 1, Medicine Faculty, Poursina st., Keshavarz blv., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh khodadadi
Position
Student
Other areas of specialty/work
Street address
No 9, Firouze alley, Patris lomomba avenue, Sattar khan avenue, Tehran, Iran