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Effects of upper and lower body resistance training on plasma levels of NADPH oxidase, CD25, TNF-α, NO, and blood pressure in hypertensive men

Protocol summary

Study aim
Investigate the effect of upper and lower body resistance training on plasma levels of NOX, CD25, TNF-α and NO, systolic, diastolic, and mean arterial blood pressure
Design
According to the call for information in this city (hospitals, pharmacies, and health centers), volunteers first register and then subjects selected purposefully based on inclusion criteria, and randomly divided into three groups of upper and lower body resistance training along with the control.
Settings and conduct
The subjects attended the briefing meeting and became acquainted with resistance training and one repetition maximum (1RM). They then took part in two separate sessions at the gym and 1RM of target muscle groups including upper body exercise (bench press, triceps extension, and lat pull down ) and lower body exercise (leg press, leg extensions, and leg curl) was measured. To determine the 1RM of target muscle groups, 5 to 10 minutes of general warm-up were initially performed, including stretching and kinetic movements. Then, the subjects participated in the 1RM test of target muscle groups using bodybuilding machines.
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
Three groups of upper body resistance training, lower body resistance training along with the control
Main outcome variables
NOX; CD25; TNF-α; NO; systolic, diastolic, and mean arterial blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181107041589N1
Registration date: 2018-11-26, 1397/09/05
Registration timing: retrospective

Last update: 2018-11-26, 1397/09/05
Update count: 0
Registration date
2018-11-26, 1397/09/05
Registrant information
Name
Marziyeh Saghebjoo
Name of organization / entity
University of Birjand
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 2042
Email address
m_saghebjoo@birjand.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
2017-06-10, 1396/03/20
Actual recruitment end date
2017-08-11, 1396/05/20
Trial completion date
2017-08-11, 1396/05/20
Scientific title
Effects of upper and lower body resistance training on plasma levels of NADPH oxidase, CD25, TNF-α, NO, and blood pressure in hypertensive men
Public title
Effects of upper and lower body resistance training on hypertension
Purpose
Treatment
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 40 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Actual sample size reached: 37
Randomization (investigator's opinion)
Randomized
Randomization description
Samples randomization were done by table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participants were unaware of the difference in training between groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Pardis campus, University of Birjand, Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717434765
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.BUMS.REC.1396.56

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
Systolic blood pressure
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Blood pressure meter

2

Description
Diastolic blood preesure
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Blood pressure meter

3

Description
Mean arterial blood pressure
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Formula

4

Description
NADPH oxidase
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Research kit

5

Description
TNF-α
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Research kit

6

Description
Nitric oxide
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Research kit

7

Description
CD25
Timepoint
Before and 4 weeks after exercise training
Method of measurement
Research kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Upper body resistance training: The resistance training program (bench press, triceps extension, and lat pull down) included four weeks (65-75% 1RM) and four sessions per week (60 minutes per session).
Category
Treatment - Other

2

Description
Intervention group: Lower body resistance training: The resistance training program (leg press, leg extensions, and leg curl) included four weeks (65-75% 1RM) and four sessions per week (60 minutes per session).
Category
Treatment - Other

3

Description
Control group: The control group did not receive any intervention and maintained a normal diet during the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Street address
Pardis campus, University of Birjand, Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3220 2042
Email
m_saghebjoo@birjand.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, University of Birjand
Full name of responsible person
Dr Hamid Reza Najafi
Street address
Pardis campus, University of Birjand, Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3220 2516
Fax
+98 56 3220 2516
Email
h.r.najafi@birjand.ac.ir
Web page address
http://www.birjand.ac.ir
Grant name
Deputy of Research and Technology, University of Birjand
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 Birjand
Proportion provided by this source
10
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
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Pardis campus, University of Birjand, Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3220 2042
Email
m_saghebjoo@birjand.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Pardis campus, University of Birjand, Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3220 2042
Email
m_saghebjoo@birjand.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Exercise Physiology, Faculty of Sport Sciences, University of Birjand, Shokat Abad-Pardis-e-Daneshgah
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3220 2042
Fax
+98 56 3220 2032
Email
m_saghebjoo@birjand.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be shared in the form of the printed article.
When the data will become available and for how long
Since 2019
To whom data/document is available
Public access to the results
Under which criteria data/document could be used
For use in controlling hypertension as a complementary treatment method under the supervision of a physician and a exercise physiologist
From where data/document is obtainable
Send email to corresponding author
What processes are involved for a request to access data/document
Send email to corresponding author
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