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The Effect of Selected Mod of Physical Activity During Shift Work on Cardiovascular Biomarkers in Sarirplast Industrial Group Workers

Protocol summary

Study aim
Determination of the effect of selected mod of physical activity during shift work on cardiovascular biomarkers in Sarirplast Industrial Group Workers
Design
The Research will be conducted with two experimental and control groups. ّAfter reviewing the data of the self-report questionnaires by shift workers, The 30 persons with the entry criteria for the research will be selected as sample in a targeted sampling. Then subjects will be assigned to one of the two groups; intervention (n = 15) and control (n = 15), randomly.
Settings and conduct
The site of the present researchwill be Dezful Industrial Group that consists of five affiliated companies. The statistical population of the survey will be all the shift workers of this industrial group. Research will be a quasi-experimental research with pre-test and post-test design with two experimental and control groups. Blinding will not be done in this research.
Participants/Inclusion and exclusion criteria
men shift workers with at least 5 years shift work no smoking Lack of chronic cardiovascular disease, uncontrolled blood pressure and respiratory diseases Lack of diseases and musculoskeletal problems Lack of diabetes, infectious and inflammatory diseases Lack of history of recurrent hypoglycemia or during exercise Not having regular exercise in the last six months
Intervention groups
The intervention will be aerobic physical activity (running), which will be performed three days a week with a rest day between the training sessions and for 8 weeks. Only the experimental group will perform the intervention.
Main outcome variables
Body Weight, Body Mass Index, Wrist Hip Ratio, Body Fat Percentage, Visceral Fat, Systolic and Diastolic Blood Pressure, Blood Lipids and Lipoprotein, Rest Heart Rate, Cardiac Troponin I, C-Reactive Protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190702044080N1
Registration date: 2019-08-30, 1398/06/08
Registration timing: registered_while_recruiting

Last update: 2019-08-30, 1398/06/08
Update count: 0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Aboutaleb Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4255 5298
Email address
talebbagheri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Selected Mod of Physical Activity During Shift Work on Cardiovascular Biomarkers in Sarirplast Industrial Group Workers
Public title
The Effect of Selected Mod of Physical Activity During Shift Work on Cardiovascular Biomarkers in Sarirplast Industrial Group Workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
men shift workers aged 25 to 40 years at least 5 years of shift work history no smoking lack of chronic cardiovascular disease lack of uncontrolled blood pressure lack of respiratory diseases lack of severe skeletal and articular problems lack of diabetes lack of infectious and inflammatory diseases lack of history of recurrent hypoglycemia or during exercise Not having regular exercise in the last six months
Exclusion criteria:
infected with other infectious diseases
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The volunteer candidates will be selected by targeted sampling. For shift workers, a random number will be assigned an identification number. So a range of 00 to 29 will be determined. Two equal groups (n = 15) will be formed. The samples will be divided into intervention and control groups using random numbers. The first number entered into the intervention group and the second to the control group; this process will continue to accommodate 15 individuals in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- Science and Research Branch
Street address
Science and Research Branch, Hessarak Blvd, University Square, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.IAU.SRB.REC.1398.007

Health conditions studied

1

Description of health condition studied
Cardiovascular biomarkers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
cardiac troponin I
Timepoint
Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
French Biosynex kit by ELISA method

2

Description
High Sensetive-C-Reactive Protein
Timepoint
Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
England Omega Diagnostics LTD kit by ELISA method

3

Description
Blood lipids and lipoproteins
Timepoint
Blood sampling 48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
by Spectophotometer device

4

Description
Systolic and diastolic blood pressure
Timepoint
48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
With Digital Blood Pressure (Norditalia BP-510, Italy) from the left wrist

5

Description
Anthropometric Indicators
Timepoint
48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
height by Seca stadimeter; body weight, body mass Index, body fat percentage, and visceral by Omron impedance bio-electrical device; and The wrist hip ratio by non-elastic meter strip

6

Description
Rest Heart Rate
Timepoint
48 hours before the first training session (intervention) and 48 hours after the last training session (intervention)
Method of measurement
With Digital Norditalia (BP-510, Italy)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: According to the World Health Organization's recommendation for weight adjustment and risk reduction of cardiovascular disease, physical activity with moderate intensity is determined for intervention group. Intervention is conducted 3 days a week with a day rest between sessions and for 8 weeks at 17-19 pm. Each session consists of 10 minutes of warm-up (running and stretching), 30 minutes of running, and 5 to 7 minutes of cool-down (running and stretching) with the examiner's supervision. To observe the principle of over-load, the physical activity of the intervention group starts at 50% of the Target Heart Rate and will reach 70% in the final weeks. The activity is controlled by the beaconometer. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision.
Category
Prevention

2

Description
Control group: No exercise intervention will be received by the researcher; only the pre-blood donation recommendations will be received. The control group will be required to inform the researcher in case of regular exercise and use of medicinal and non-prescriptive supplements, in order to eliminate them if necessary. So high-fatty foods (especially for shimmering) will be eliminated. This will be controlled by the supervision.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sarirplast Industrial Group Workers
Full name of responsible person
Mohsen Ghasaban Nezhad
Street address
4th st, Industrial Town No. 1
City
Dezful
Province
Khouzestan
Postal code
1234567899
Phone
+98 61 4242 9897
Email
mohsen_adiban@yahoo.com
Web page address
http://sarirplast.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Heidari Moghadam
Street address
Dezful Islamic Azad University, University blvd, Azadegan
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0601
Email
rvp@iaud.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
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nader Shakeri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University Science and Research Branch, Hessarak blvd, University Square, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1669445564
Phone
+98 21 4486 5179
Email
nsprofsport@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nader Shakeri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University Science and Research Branch, Hessarak blvd, University Square, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1669445564
Phone
+98 21 4486 5179
Email
nsprofsport@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aboutaleb Bagheri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University-Dezful Branch, University blvd
City
Dezful
Province
Khouzestan
Postal code
6461837894
Phone
+98 61 4255 5298
Email
talebbagheri@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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