Effect of eight weeks resistance training in land and water on lipid profile change and the blood mononuclear cells PPAR-ɑ and ABCG8 gene expression in middle-aged women after Coronary Artery Bypass Grafting
Regarding the relationship between reverse cholesterol transport and cardiovascular diseases, the positive effect of physical activities on key factors affecting this process the current study is aimed at examining PPAR α gene expression in peripheral blood mononuclear cells (PBMNCs) in middle-aged women having had CABG, after 8 weeks of aquatic and dryland resistance training programs.
Design
In this research, thirty cardiac patient volunteer (aged 43-56 years) who meet the inclusion criteria will be selected for this study from the entire population.
Settings and conduct
This research is carried out as per-test and post-test. Middle-aged women with cardiovascular disease that refer to Shafa Hospital in Kerman will includes. Fasting blood samples will take from all participants 48 hours both before the beginning and after the last training session. PPARα and ABCG8 relative gene expression will identify by Real-Time PCR method from PBMN cells.
Participants/Inclusion and exclusion criteria
Patients were included in the study if they had undergone coronary artery bypass 3 months before the study and were relatively fit to carry out the exercises and . Patients were excluded from this study if they had unstable angina, decompensated heart failure, myocardial infarction , problematic ventricular arrhythmias
Intervention groups
Following a random screening, the participants were divided into control group , the aquatic resistance training group and dryland resistance training group .Exercise training protocol includes eight weeks of resistance training (3 days a week / 60 minutes per session) and consisted of warm-up (10 minutes), main activity (30 to 40 minutes) and cooling down (10 minutes) . In this period control group will have no physical activity except doing things everyday life.
Main outcome variables
Improve physical function, improve mental and social status of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180113038343N1
Registration date:2018-02-19, 1396/11/30
Registration timing:registered_while_recruiting
Last update:2018-02-19, 1396/11/30
Update count:0
Registration date
2018-02-19, 1396/11/30
Registrant information
Name
Leili Zeiaadini Dashtkhaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3244 5365
Email address
lzeiaadini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-25, 1396/11/05
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eight weeks resistance training in land and water on lipid profile change and the blood mononuclear cells PPAR-ɑ and ABCG8 gene expression in middle-aged women after Coronary Artery Bypass Grafting
Public title
Effect of resistance training in cardiac rehabilitation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients were included in the study if they had already had coronary bypass, had a homogeneous level of the disease, and had undergone coronary artery bypass in 3 months ago
Patients were relatively fit to carry out the exercises
Exclusion criteria:
Patients were excluded from this study if they had unstable angina, decompensated heart failure,,
Myocardial infarction within the last month and problematic ventricular arrhythmias
Any other limitations examined by the doctor in period of training
Age
From 43 years old to 56 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Following a random screening, the participants were divided into control group (CON) (n = 10), the aquatic resistance training group (ART) (n = 10) and dryland resistance training group (DRT) (n = 10). The randomization method will be random numbers. Considering that, numbers 0 -10 for the control group, numbers 10 -20 for dryland resistance training and numbers 20-30 for aquatic resistance training. The researcher starts on one of the numbers and moves in the preset direction, then records the number and specifies the relevant group.
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
Physical Education and Sport Science Research Center
Street address
No.3 , 5 Miremad Ave
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SSRI.REC.1396.142
Health conditions studied
1
Description of health condition studied
Rehabilitation with Aquatic and Dryland Resistance Training on Middle-aged Women’s PBMN Cells after Coronary Artery Bypass Grafting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PPAR α Gene Expression
Timepoint
At the beginning of the research and 8 weeks after doing intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
ABCG8 gene expression
Timepoint
At the beginning of the research and 8 weeks after doing intervention
Method of measurement
blood sample
2
Description
Lipid profile
Timepoint
At the beginning of the research and 8 weeks after doing intervention
Method of measurement
blood sample
Intervention groups
1
Description
Intervention group:Intervention group 1 will do aquatic resistance training: Aquatic training will take place in a shallow pool (120 cm deep) at a temperature between 28-30oC. Aquatic training exercises (with 60 to 80% of one-repetition maximum for each exercise)will last for 8 weeks (3 sessions per week/ 60 minutes per session) and will be include a warm-up (10 minutes), main activity (30-40 minutes) and cooling down (10 minutes). The main activity consist of 3 sets of upper-body dumbbell exercises including: shoulder shrugs, shoulder horizontal extension, shoulder extension with external rotation, and shoulder press with rotation, and lower body exercises with ankle weights including standing leg curls, supported squats, inner and outer thigh abduction, and sliding backward and forward with partial to full ranges of motion, with 8 repetitions during the first four weeks, and 10 repetitions during the fifth to eighth weeks. The training program of each session will differ from other sessions, and base on the principles of kinesiology, exercise science and hydrodynamics
Category
Rehabilitation
2
Description
Intervention group 2: Dryland resistance training: Dryland training program will be include eight weeks of resistance training (3 days a week / 60 minutes per session) and consist of warm-up (10 minutes), main activity (30 to 40 minutes) and cooling down (10 minutes). The main activity will be 8 resistance sessions. It will be include machine bench press, seated cable row, inner thigh movements, Lat pull down, Pec deck, outer thigh movements, curl-ups, hyper-extension with 2-3 sets of 12-15 repetitions with 60 % of one-repetition maximum. There are 30-second rests between exercises, and 5-minute rests between sets. One-repetition maximum test will repeat at the end of the fourth week to adjust the training protocol to the changes. Based on the results obtain through this test, the training protocol will continue until the end of the eighth week.
Category
Rehabilitation
3
Description
Control group: This group will do no physical activity except everyday life affairs.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Leili Zeiaadini Dashtkhaki
Street address
Safa Ave., Parastar Blvd
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3244 5365
Fax
+98 34 3211 5783
Email
shafahospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Neyshabur
Full name of responsible person
Mohammad Hossein Hemati
Street address
Pajoohesh Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319797139
Phone
+98 51 4262 1901
Fax
+98 51 4261 5472
Email
Neyshabur@iau-neyshabur.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Neyshabur
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Neyshabur
Full name of responsible person
Leili Zeiaadini Dashtkhaki
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.5, North Elahieh Ave., Nasr Blvd
City
Kerman
Province
Kerman
Postal code
7618697677
Phone
+98 34 3244 5365
Email
lzeiaadini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Neyshabur
Full name of responsible person
Leili Zeiaadini Dashtkhaki
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 5, Elahieh Ave., Nasr Blvd
City
Kerman
Province
Kerman
Postal code
7618697677
Phone
+98 34 3244 5365
Email
lzeiaadini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Neyshabur
Full name of responsible person
Leili Zeiaadini Dashtkhaki
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 5, North Elaheih Ave., Nasr Blvd
City
Kerman
Province
Kerman
Postal code
7618697677
Phone
+98 34 3244 5365
Email
lzeiaadini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data of PPAR α and ABCG8 Gene Expression and lipid profile will be report
When the data will become available and for how long
From 18 April 2018
To whom data/document is available
University researchers
Under which criteria data/document could be used
Mention reference
From where data/document is obtainable
lzeiaadini@yahoo.com
What processes are involved for a request to access data/document