Evaluation the effect of physiotherapy and cardiac rehabilitation on serum and salivary level of interleukin 6, lipid profile and anthropometric measures of obesity in patients with coronary artery disease
The objective of this study is to evaluate the effect of an exercise based cardiac rehabilitation program on serum and salivary concentrations of IL-6, in relation to the anthropometric measures of obesity and lipid profile.
Sixty non diabetic volunteers with coronary artery disease participate in 6-8 weeks of moderate intensity aerobic exercise training consisting of 45 min sessions of treadmill, stationary bicycle and arm ergometer. Anthropometric measures of obesity (body mass index, waist circumference, hip circumference, waist to hip ratio and waist to height ratio), levels of IL-6 concentration in the serum, stimulated and non stimulated saliva will be measured at the beginning, in the middle and at the end of exercise sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207121662N1
Registration date:2012-11-06, 1391/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Behrouz Attarbashi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 9609
Email address
attarbashi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of physiotherapy and cardiac rehabilitation on serum and salivary level of interleukin 6, lipid profile and anthropometric measures of obesity in patients with coronary artery disease
Public title
The effect of physiotherapy and cardiac rehabilitation in lipid profile and anthropomorphic measurements of obesity
Purpose
Basic scienece
Inclusion/Exclusion criteria
Iinclusion criteria: low risk cardiac patients; intermediate risk cardiac patients
Exclusion criteria: high risk patients; patient disagreement to continue the project
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blv.-Ghods Ave.
City
Tehran
Postal code
Approval date
2012-09-25, 1391/07/04
Ethics committee reference number
65516-16954-32-02-91
Health conditions studied
1
Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
2
Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Salivary IL-6
Timepoint
first session-12th session- after 24th session
Method of measurement
elisa method
2
Description
Serum IL-6
Timepoint
first session- after 24th session
Method of measurement
elisa method
3
Description
anthropometric index
Timepoint
first session-12th session- after 24th session
Method of measurement
Kg, meter, nonelastic meter
4
Description
lipid profile
Timepoint
first session- after 24th session
Method of measurement
elisa method
Secondary outcomes
empty
Intervention groups
1
Description
Cardiac rehabilitation
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mostafa Nejatian
Street address
Near Shariati Hospital, North Kargar street
City
Tehran
2
Recruitment center
Name of recruitment center
AJA University of Medical Sciences
Full name of responsible person
Iraj Mirzaii-Dizgah
Street address
Nasr bridge, Chamran Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. M Yunesian
Street address
Tehran University of Medical Sciences, Vice dean for research, Ghods Ave., Keshavarz Blv.
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
Tehra University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Ph.D.
Other areas of specialty/work
Street address
School of Rehabilitation, Nezam street, Shah nazary street, Mirdamad Ave.
City
Tehran
Postal code
Phone
+98 21 2226 9609
Fax
Email
attarbashi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Ph.D.
Other areas of specialty/work
Street address
School of Rehabilitation, Nezam Street, Shah Nazari Street, Madar Sq., Mirdamad Ave.
City
Tehran
Postal code
Phone
+98 21 2226 9609
Fax
Email
attarbashi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
School of rehabilitation, Nezam Street, Shah Nazari Street, Madar Sq., Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2226 9609
Fax
Email
attarbashi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)