Compatibility of hemodynamic and biochemical markers related to high blood pressure of older men; a long period of resistance training and consumption of saffron
The effect of long-term resistance training and saffron consumption on hemodynamic and biochemical markers related to high blood pressure of older men
Design
volunteers first register and then subjects selected purposefully based on inclusion criteria, and randomly divided into Four groups of resistance training, saffron, resistance training + saffron and control.
Settings and conduct
Subjects in resistance training groups and saffron + resistance training groups performed the resistance training protocol for twelve weeks (3 days per week). also Subjects in the saffron and resistance training + saffron groups consumed one tablet (200 mg) of saffron daily for twelve weeks.Blood pressure and blood sampling were measured in several stages.
Participants/Inclusion and exclusion criteria
The criteria for including the subjects were primary hypertension; absence of heart disease which prevented exercise; and absence of diabetes. Also, they had no history of performing regular exercise in the six months leading up to the study, and their systolic blood pressure ranged from 140-159 mm Hg and diastolic blood pressure lied within the range of 90-99 mm Hg .
Intervention groups
Four groups of resistance training, saffron, resistance training + saffron and control
Main outcome variables
Effect of resistance training and saffron consumption on blood pressure; ANP; CD25; Nitric Oxide; Adiponectin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044398N1
Registration date:2019-08-15, 1398/05/24
Registration timing:retrospective
Last update:2019-08-15, 1398/05/24
Update count:0
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
Babak Hooshmand Moghadam
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 0540
Email address
babak.hooshmand@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
2019-04-09, 1398/01/20
Actual recruitment end date
2019-07-11, 1398/04/20
Trial completion date
2019-07-11, 1398/04/20
Scientific title
Compatibility of hemodynamic and biochemical markers related to high blood pressure of older men; a long period of resistance training and consumption of saffron
Public title
Compatibility of hemodynamic and biochemical markers related to high blood pressure of older men; a long period of resistance training and consumption of saffron
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for including the subjects were primary hypertension
absence of heart disease which prevented exercise, and absence of diabetes
They had no history of performing regular exercise in the six months leading up to the study
Their systolic blood pressure ranged from 140-159 mm Hg and diastolic blood pressure lied within the range of 90-99 mm Hg
Exclusion criteria:
Participation in exercise training programs other than the exercise training program of the present study
Age
From 50 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, simple randomization method with random number Table method was used. This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the present direction and recorded the numbers for that direction in the target group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, participants are unaware of the group assigned to themselves and other participants. A separate workout hour is considered for each intervention group. experts in laboratory analysis are also unaware of the type of intervention and the participating groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Physical Education and Sport Sciences
Street address
impasse 5, district 7, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.020
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before and 2، 4، 6، 8، 10، 12، 14، 16، 18 weeks after intervention
Method of measurement
Blood pressure mannometer (mmHg)
2
Description
Serum levels of ANP
Timepoint
Before and 6، 12، 18 weeks after intervention
Method of measurement
Blood sampling and using ELISA method
3
Description
Serum levels of CD25
Timepoint
Before and 6، 12، 18 weeks after intervention
Method of measurement
Blood sampling and using ELISA method
4
Description
Serum levels of nitric acid
Timepoint
Before and 6، 12، 18 weeks after intervention
Method of measurement
Blood sampling and using ELISA method
5
Description
Serum levels of adiponectin
Timepoint
Before and 6، 12، 18 weeks after intervention
Method of measurement
Blood sampling and using ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training group performed 12 weeks and each week 3 sessions of resistance training.
Category
Other
2
Description
Intervention group: The saffron group consumed 200 mg of saffron for 12 weeks.
Category
Other
3
Description
Intervention group: The saffron + training group performed resistance training program for 12 weeks and 3 sessions per week and consumed 200 mg saffron daily.
Category
Other
4
Description
Control group: The control group did not perform resistance training and did not consume saffron.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Babak Hooshmand Hoghadam
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8835 1730
Email
b.hooshmand.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, University of Tehran
Full name of responsible person
Fetemeh Shabkhiz
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8835 1730
Email
shabkhiz@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, University of Tehran
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fetemeh Shabkhiz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, Tehran University , North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8835 1730
Email
shabkhiz@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fetemeh Shabkhiz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, Tehran University , North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8835 1730
Email
shabkhiz@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Babak Hooshmand Hoghadam
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Northern Kargar Ave
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 8835 1730
Email
b.hooshmand.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Personal information of patients is confidential. But access to the research method and the information obtained from the research is not a problem
When the data will become available and for how long
After printing in a journal
To whom data/document is available
All students and enthusiasts
Under which criteria data/document could be used
In order to use data to carry out research work in this area
From where data/document is obtainable
The authors of this article b.hooshmand.m@gmail.com
What processes are involved for a request to access data/document
By sending email the author will work with the applicant as soon as possible