Determining the effect of comprehensive cardiac rehabilitation on the health promoting lifestyle of individuals with implantable cardioverter defibrillators
Design
Quasi-experimental, including control group, parallel, non-blinded, non-randomized of 70 participants
Settings and conduct
Selection of available samples from Shahid Faghihi Hospital and Al-Zahra Heart Hospital affiliated to Shiraz University of Medical Sciences and non-randomly assigned to two groups of control and intervention
Participants/Inclusion and exclusion criteria
Inclusion:
Age 18- 60 years old;
At least 3 months passed from the insertion of implantable cardioverter defibrillator;
Hearing and vision and perception in communication;
Exclusion:
Neurological, cognitive and motor disorders, according to documents;
Other than sinus rhythm or ventricular tachycardia in the pre-intervention analysis;
Intervention groups
Comprehensive cardiac rehabilitation program is conducted for 5 weeks, 2 sessions each week, for a period of 1.5 hours, including 45 minutes of physical activity and 45 minutes of educational intervention in the intervention group. No intervention is performed in control group.
Main outcome variables
Physical activity and nutrition dimensions from health promotion lifestyle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040122N1
Registration date:2018-07-09, 1397/04/18
Registration timing:retrospective
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Mahnaz Siahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
siahi.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
empty
Scientific title
Efficacy of Comprehensive Cardiac Rehabilitation on Health Promoting Lifestyle in People with Implantable Cardioverter Defibrillator
Public title
The effect of cardiac rehabilitation in people with cardiac defibrillator
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years old
At least 3 months passed from insertion of implantable cardioverter defibrillator
Hearing and vision and perception in communication
Exclusion criteria:
Neurological, cognitive and motor disorders, according to documents
Other than sinus rythm or ventricular tachycardia in the pre-intervention analysis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
72
Randomization (investigator's opinion)
Not 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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.IUMS.FMD.REC 1396.931168900
Health conditions studied
1
Description of health condition studied
Individuals with implantable cardioverter defibrillator
ICD-10 code
I46.2
ICD-10 code description
Cardiac arrest due to underlying cardiac condition
Primary outcomes
1
Description
Nutrition
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Health promoting lifestyle Questionnaire
2
Description
Physical activity
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Health promoting lifestyle Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Comprehensive cardiac rehabilitation intervention was performed for 10 sessions in 5 weeks, 2 sessions per week, 1.5 hours per session. At the beginning of each session, the exercise intervention was performed for 45 minutes by the researcher under the supervision of a physiotherapist in the intervention group, which included 10 minutes of warm up, 8 minutes of bicycle, 8 minutes of running or walking, 8 minutes of aerobic training, and at the end, 10 minutes of cool down. Then, the educational intervention includes nutrition education and physical activity and reduction of cardiovascular risk factors was carried out by the researcher at the end of each session of physical training for 45 minutes.
Category
Other
2
Description
Control group: No intervention was done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Mahnaz Siahi
Street address
Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Cardiovascular Hospital
Full name of responsible person
Mahnaz Siahi
Street address
Sibouye Blv. Alzahra Cardiovascular Hospital
City
Shiraz
Province
Fars
Postal code
7164954937
Phone
+98 71 3739 8811
Email
hfcmanager@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Siahi
Position
Rehabilitation Nursing Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran Faculty of Nursing and Midwifery, Rashid Yasemi Ave., Vanak Sq., Vali Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
m.siahi8361@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ezzat Jafar Jalal
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Iran Faculty of Nursing and Midwifery, Rashid Yasemi Ave., Vanak Sq., Vali Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Email
Ejalal2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Siahi
Position
Rehabilitation Nursing Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran Faculty of Nursing and Midwifery, Rashid Yasemi Ave., Vanak Sq., Vali Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
m.siahi8361@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after unidentifying Individuals.
When the data will become available and for how long
Accessible 6 months after result publication
To whom data/document is available
Data will be available just for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to cite in other researches
From where data/document is obtainable
m.siahi8361@gmail.com
What processes are involved for a request to access data/document